Infusion Center

Welcome to Pima Neurology, your premier infusion center specializing in neurological conditions. At Pima Neurology, we understand the unique challenges faced by individuals living with neurological disorders and strive to provide comprehensive and personalized care. Our infusion services cater to a wide range of conditions, including multiple sclerosis, Alzheimer’s disease, myasthenia gravis, neuropathy and migraines.

Neurological conditions can significantly impact one’s quality of life, often requiring specialized treatments to manage symptoms effectively. Infusion therapy has emerged as a groundbreaking treatment option, offering targeted relief and improved outcomes for patients with various neurological disorders. Our team of experienced neurologists and healthcare professionals is dedicated to delivering cutting-edge infusion therapies tailored to each patient’s specific needs.

For individuals living with multiple sclerosis (MS), Pima Neurology offers infusion treatments that can help alleviate symptoms and slow the progression of the disease. Our highly trained staff administers disease-modifying therapies, including monoclonal antibodies and immunomodulators, which have shown promising results in managing MS and enhancing patients’ quality of life.

The following (MS) infusions Pima Neurology offers are:

BRIUMVI (ublituximab-xiiy)

OCREVUS (ocrelizumab)

SOLU-MEDROL (methylprednisolone)

TYSABRI (natalizumab)

Alzheimer’s disease, a progressive and debilitating neurological disorder, requires a multifaceted approach to treatment. At Pima Neurology, we offer infusion therapies designed to target the underlying mechanisms of Alzheimer’s, such as beta-amyloid plaque formation and neuroinflammation. These therapies aim to slow down the cognitive decline associated with the disease and improve patients’ cognitive function and overall well-being. Effective July 2023 we now have the ability to offer a new medication to our patients with Alzheimer’s.

LEQEMBI (lecanemab-irmb)

Myasthenia gravis, a chronic autoimmune neuromuscular disorder, can cause muscle weakness and fatigue. Our infusion center provides therapies, including intravenous immunoglobulin (IVIG), to help manage the symptoms of myasthenia gravis and enhance patients’ strength and mobility. The following myasthenia gravis medications are:

VYVGART (efgartigimod alfa-fcab)

ULTOMIRIS (ravulizumab-cwvz)

IV/IG’s

Migraine, a common neurological disorder characterized by severe headaches and other debilitating symptoms, can significantly impact daily life. Pima Neurology offers migraine infusion therapies that target the underlying causes of migraines and provide relief from acute attacks. These infusion treatments can help reduce the frequency, intensity, and duration of migraines, allowing patients to regain control over their lives. We offer a medication that is used for the preventative treatment of migraines known as:

VYEPTI® (eptinezumab-jjmr)

At Pima Neurology, we understand the importance of customized care for neurological conditions. Our infusion center is equipped with state-of-the-art facilities and staffed by a compassionate team of experts who are dedicated to ensuring your comfort and safety throughout the treatment process. We prioritize patient well-being and strive to create a supportive and nurturing environment for all individuals who seek our services.

Whether you are seeking infusion therapy for multiple sclerosis, Alzheimer’s disease, myasthenia gravis, or migraines, Pima Neurology is here to provide you with the highest standard of care. Our commitment to excellence, combined with our comprehensive range of infusion treatments, makes us a trusted partner in your journey towards improved neurological health.

Contact us today to schedule a consultation and learn more about how infusion therapies at Pima Neurology can make a positive difference in your life. Together, we can navigate the complexities of neurological conditions and strive towards a brighter, healthier future.

What is ULTOMIRIS?

ULTOMIRIS is a prescription medicine called a monoclonal antibody. ULTOMIRIS is used to treat:

  • Adults and children 1 month of age and older with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH).
  • Adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS).

ULTOMIRIS is not used in treating people with Shiga toxin E. coli-related hemolytic uremic syndrome (STECHUS).

  • Adults with a disease called generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

ULTOMIRIS is a medicine that affects your immune system. ULTOMIRIS can lower the ability of your immune system to fight infections.

  • ULTOMIRIS increases your chance of getting serious and life-threatening meningococcal infections. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early.
  1. You must receive meningococcal vaccines at least 2 weeks before your first dose of ULTOMIRIS if you have not already had this vaccine.
  2. If your healthcare provider decides that urgent treatment with ULTOMIRIS is needed, you should receive meningococcal vaccination as soon as possible.
  3. If you have not been vaccinated for meningococcal infections and ULTOMIRIS therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations.
  4. If you had a meningococcal vaccine in the past, you might need additional vaccination before starting ULTOMIRIS. Your healthcare provider will decide if you need additional meningococcal vaccination.
  5. Meningococcal vaccines reduce the risk of meningococcal infection but do not prevent all meningococcal infections.

Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection:

  • Headache with nausea or vomiting
  • Headache with a stiff neck or stiff back
  • Fever and a rash
  • Muscle aches with flu-like symptoms
  • Headache and fever
  • Fever
  • Confusion
  • Eyes sensitive to light

Your healthcare provider will give you a Patient Safety Card about the risk of meningococcal infection. Carry it with you at all times during treatment and for 8 months after your last ULTOMIRIS dose. Your risk of meningococcal infection may continue for several months after your last dose of ULTOMIRIS. It is important to show this card to any healthcare provider or nurse who treats you. This will help them diagnose and treat you quickly.

ULTOMIRIS is only available through a program called the ULTOMIRIS REMS. Before you can receive ULTOMIRIS, your healthcare provider must:

  • Enroll in the ULTOMIRIS REMS program.
  • Counsel you about the risk of meningococcal infection.
  • Give you information about the symptoms of meningococcal infection.
  • Give you a Patient Safety Card about your risk of meningococcal infection, as discussed above.
  • Make sure that you are vaccinated with a meningococcal vaccine, and if needed, get revaccinated with the meningococcal vaccine. Ask your healthcare provider if you are not sure if you need to be revaccinated.

ULTOMIRIS may also increase the risk of other types of serious infections.

  • People who take ULTOMIRIS may have an increased risk of getting infections caused by Streptococcus pneumoniae and Haemophilus influenzae.
  • If your child is treated with ULTOMIRIS, make sure that your child receives vaccinations against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib).
  • Certain people may also have an increased risk of gonorrhea infection. Talk to your healthcare provider to find out if you are at risk for gonorrhea infection, about gonorrhea prevention, and about regular testing.

Call your healthcare provider right away if you have any new signs or symptoms of infection.

Who should not receive ULTOMIRIS?

Do not receive ULTOMIRIS if you:

  • Have a meningococcal infection.
  • Have not been vaccinated against meningococcal infection unless your healthcare provider decides that urgent treatment with ULTOMIRIS is needed. See “What is the most important information I should know about ULTOMIRIS.”

Before you receive ULTOMIRIS, tell your healthcare provider about all of your medical conditions, including if you:

  • Have an infection or fever.
  • Are pregnant or plan to become pregnant. It is not known if ULTOMIRIS will harm your unborn baby.
  • Are breastfeeding or plan to breastfeed. It is not known if ULTOMIRIS passes into your breast milk. You should not breastfeed during treatment and for 8 months after your final dose of ULTOMIRIS.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ULTOMIRIS and other medicines can affect each other causing side effects.

Know the medicines you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I receive ULTOMIRIS?

  • Your healthcare provider will decide how long you need to receive ULTOMIRIS for your PNH, your aHUS, or your gMG.

Adults with PNH, aHUS, or gMG when administered intravenously (by vein)

  • You will be given intravenous ULTOMIRIS infusion by a healthcare provider through a needle placed in a vein.
  • You will usually receive: A starting dose of intravenous ULTOMIRIS infusion by your healthcare provider, and then 2 weeks later, you will start to receive an infusion of ULTOMIRIS every 8 weeks.

Adults with PNH or aHUS when administered subcutaneously (under your skin)

  • You or your caregiver will administer subcutaneous ULTOMIRIS under your skin through an on-body injector.
  • Use ULTOMIRIS exactly as your healthcare provider tells you to.
  • Read the Instructions for Use that comes with subcutaneous ULTOMIRIS for instructions about the right way to prepare and give your subcutaneous ULTOMIRIS injections through an on-body injector.
  • If your healthcare provider decides that you or a caregiver can give you injections of subcutaneous

ULTOMIRIS, you or your caregiver should receive training on the right way to prepare and inject subcutaneous ULTOMIRIS. It is important that you receive training from your healthcare provider on how to inject subcutaneous ULTOMIRIS before giving an injection.

  • You will need 2 on-body delivery systems (each containing 1 on-body injector and 1 prefilled cartridge) for a full subcutaneous ULTOMIRIS dose, and each injection will take about 10 minutes.
  • You or your caregiver can administer the injections at the same time or 1 after the other into your stomach (abdomen), thigh, or upper arm.
  • If you are not currently being treated with intravenous ULTOMIRIS or SOLIRIS, you will usually receive: A starting dose of intravenous ULTOMIRIS infusion from your healthcare provider, and then 2 weeks later, you or your caregiver will start to administer maintenance doses of subcutaneous ULTOMIRIS weekly.

If you are changing treatment between ULTOMIRIS administered intravenously, ULTOMIRIS administered subcutaneously, or SOLIRIS:

  • From intravenous ULTOMIRIS to subcutaneous ULTOMIRIS, you should receive your first dose of subcutaneous ULTOMIRIS 8 weeks after your last dose of intravenous ULTOMIRIS. No intravenous ULTOMIRIS starting dose is needed.
  • From subcutaneous ULTOMIRIS to intravenous ULTOMIRIS, you should receive your first dose of intravenous ULTOMIRIS 1 week after your last dose of subcutaneous ULTOMIRIS.
  • From SOLIRIS to intravenous ULTOMIRIS, you should receive your starting dose of intravenous ULTOMIRIS at time of your next scheduled dose of SOLIRIS.
  • From SOLIRIS to subcutaneous ULTOMIRIS, you should receive your starting dose of intravenous ULTOMIRIS at time of your next scheduled dose of SOLIRIS, and then your first dose of subcutaneous ULTOMIRIS 2 weeks after your starting dose of intravenous ULTOMIRIS.
  • After each administration, you should monitor for allergic and infusion reactions for at least 1 hour. See “What are the possible side effects of ULTOMIRIS?”
  • If you have PNH and you stop receiving ULTOMIRIS, your healthcare provider will need to monitor you closely for at least 16 weeks after you stop ULTOMIRIS. Stopping ULTOMIRIS may cause breakdown of your red blood cells due to PNH. Symptoms or problems that can happen due to red blood cell breakdown include: o drop in your red blood cell count o tiredness o blood in your urine o stomach-area (abdomen) pain o shortness of breath o blood clots o trouble swallowing o erectile dysfunction (ED) in males
  • If you have aHUS, your healthcare provider will need to monitor you closely for at least 12 months after stopping treatment for signs of worsening aHUS or problems related to a type of abnormal clotting and breakdown of your red blood cells called thrombotic microangiopathy (TMA).

Symptoms or problems that can happen with TMA may include:

  • Confusion or loss of consciousness
  • Seizures
  • Chest pain (angina)
  • Difficulty breathing
  • Blood clots or stroke

If you miss an ULTOMIRIS intravenous or subcutaneous dose, or administer a partial subcutaneous dose of ULTOMIRIS, call your healthcare provider right away.

What are the possible side effects of ULTOMIRIS? ULTOMIRIS can cause serious side effects including: See “What is the most important information I should know about ULTOMIRIS?”

  • Infusion-related reactions. Infusion-related reactions may happen during your ULTOMIRIS intravenous or subcutaneous treatment. Symptoms of an infusion-related reaction with ULTOMIRIS may include lower back pain, tiredness, feeling faint, discomfort in your arms or legs, bad taste, or drowsiness. Stop treatment of ULTOMIRIS and tell your healthcare provider right away if you develop these symptoms, or any other symptoms during your ULTOMIRIS infusion that may mean you are having a serious infusion reaction, including:
  • Chest pain
  • Trouble breathing or shortness of breath
  • Swelling of your face, tongue, or throat
  • Feel faint or pass out
  • Allergic reactions to acrylic adhesive. Allergic reactions to the acrylic adhesive may happen with your subcutaneous ULTOMIRIS treatment. If you have an allergic reaction during the delivery of subcutaneous ULTOMIRIS, remove the on-body injector and get medical help right away. Your healthcare provider may treat you with medicines to help prevent or treat allergic reaction symptoms as needed.

The most common side effects of ULTOMIRIS in people treated for PNH are:

  • Upper respiratory tract infection
  • Local injection site reactions
  • Headache
  • Diarrhea

The most common side effects of ULTOMIRIS in people treated for aHUS are:

  • Upper respiratory tract infection
  • Diarrhea
  • Nausea
  • Vomiting
  • Headache
  • High blood pressure
  • Fever

The most common side effects of ULTOMIRIS in people with gMG are:

  • Diarrhea
  • Upper respiratory tract infections

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all of the possible side effects of ULTOMIRIS.

General information about the safe and effective use of ULTOMIRIS.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about ULTOMIRIS that is written for health professionals.

What are the ingredients in ULTOMIRIS?

Active ingredient: ravulizumab-cwvz.

Inactive ingredients:

Intravenous:

ULTOMIRIS 100 mg/mL: L-arginine, polysorbate 80 (vegetable origin), sodium phosphate dibasic, sodium phosphate monobasic, sucrose and Water for Injection.

ULTOMIRIS 10 mg/mL: polysorbate 80 (vegetable origin), sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic and Water for Injection.

Subcutaneous:

ULTOMIRIS 70 mg/mL: L-arginine, polysorbate 80 (vegetable origin), sodium phosphate dibasic, sodium phosphate monobasic, sucrose, and Water for Injection.

VYVGART® (efgartigimod alfa-fcab) is indicated for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

VYVGART (efgartigimod alfa-fcab) injection is a sterile, preservation free, clear to slightly opalescent, colorless to slightly yellow solution supplied in a single-dose vial for infusion after dilution. The volume of distribution is 15 to 20L.

What does vyvgart contain?

Each 20mL single-dose vial contains 400mg of efgartigimod alfa-fcab at a concentration of 20mg/mL. In addition, each mL of solution contains L-arginine hydrochloride (31.6 mg), plysorbate 80 (0.2 mg), sodium chloride (5.8 mg), sodium phosphate dibasic anhydrous (2.4 mg), sodium phosphate monobasic monohydrate (1.1 mg) and water for injection, USP, at a pH of 6.7.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about VYVGART?

VYVGART may increase the risk of infection:

  • VYVGART may increase the risk of infection. The most common infections observed in Study 1 were urinary tract infection (10% for VYVGART vs 5% for placebo) and respiratory tract infection (33% for VYVGART vs 29% for placebo). Patients on VYVGART vs placebo had below normal levels for white blood cell counts (12% vs 5%, respectively), lymphocyte counts (28% vs 19%, respectively), and neutrophil counts (13% vs 6%, respectively). The majority of infections and hematologic abnormalities were mild to moderate in severity.
  • Delay VYVGART administration in patients with an active infection until the infection is resolved; monitor for clinical signs and symptoms of infections. If serious infection occurs, administer appropriate treatment and consider withholding VYVGART until the infection has resolved.
  • Patients are instructed to communicate any history of infections to the healthcare provider and to contact their healthcare provider if they develop any symptoms of an infection.

IMMUNIZATION

  • Patients are advised to complete age-appropriate vaccines according to immunization guidelines prior to initiation of a new treatment cycle with VYVGART
  • Administration of live or live-attenuated vaccines is not recommended during treatment with VYVGART.

HYPERSENSITIVITY REACTIONS

  • Hypersensitivity reactions, including rash, swelling under the skin, shortness of breath, angioedema, and dyspnea, were observed with VYVGART. In clinical trials, hypersensitivity reactions were mild or moderate, occurred within 1 hour to 3 weeks of administration, and did not lead to treatment discontinuation. Monitor patients during administration and for 1 hour thereafter for clinical signs and symptoms of hypersensitivity reactions. If a hypersensitivity reaction occurs during administration, discontinue VYVGART infusion and institute appropriate supportive measures if needed.
  • Patients are advised to contact their healthcare provider immediately for signs or symptoms of hypersensitivity reactions.
  • If hypersensitivity reaction occurs during administration, administration of the medication will be discontinued.

ADVERSE REACTIONS

  • The most common (≥10%) adverse reactions with VYVGART were respiratory tract infection, headache, and urinary tract infection.

PREGNANCY

  • As VYVGART is expected to reduce maternal IgG antibody levels, reduction in passive protection to the newborn is anticipated. Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to VYVGART in utero.
  • Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Therefore, efgartigimod alfa-fcab may be transmitted from the mother to the developing fetus.

LACTATION

  • There is no information regarding the presence of VYVGART in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VYVGART and any potential adverse effects on the breastfed infant from VYVGART or from the underlying maternal condition.

PEDIACTRIC USE

  • Safety and effectiveness in pediatric patients have not been established.

GERIATRIC USE

  • Clinical studies of VYVGART did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger adult patients.

METABOLISM AND ELIMINATION

  • Efgartigimod alfa-fcab is expected to be degraded by proteolytic enzymes into small peptides and amino acids.
  • The terminal half-life is 80 to 120 hours (3 to 5 days).

DRUG INTERACTION STUDIES

  • Clinical drug interactions studies have not been performed with efgartigimod alfa-fcab.

OCREVUS is indicated for the treatment of:

  • Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
  • Primary progressive MS, in adults.
  • It is not known if OCREVUS is safe and effective in children.

Who should not receive OCREVUS?

  • Do not receive OCREVUS if you have an active hepatitis B virus (HBV) infection.
  • Do not receive OCREVUS if you have had a life-threatening allergic reaction to OCREVUS.

Tell your healthcare provider if you have had an allergic reaction to OCREVUS or any of its ingredients in the past.

WHAT IS the most important information i should know about ocrevus?

Before receiving OCREVUS, tell your healthcare provider about all of your medical conditions, including if you:

  • Have or think you have an infection.
  • Have ever taken, take, or plan to take medicines that affect your immune system, or other treatments for MS. These medicines could increase your risk of getting an infection.
  • Have ever had hepatitis B or are a carrier of the hepatitis B virus.
  • Have a history of inflammatory bowel disease or colitis.
  • Have had a recent vaccination or are scheduled to receive any vaccinations.

You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment with OCREVUS. You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with OCREVUS and until your healthcare provider tells you that your immune system is no longer weakened.

  • When possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with OCREVUS. If you would like to receive any non-live (inactivated) vaccines, including the seasonal flu vaccine, while you are being treated with OCREVUS, talk to your healthcare provider.
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • If you have a baby and you received OCREVUS during your pregnancy, it is important to tell your baby’s healthcare provider about receiving OCREVUS so they can decide when your baby should be vaccinated.
  • If you are pregnant, or think that you might be pregnant, or plan to become pregnant. It is not known if OCREVUS will harm your unborn baby. You should use birth control (contraception) during treatment with OCREVUS and for 6 months after your last infusion of OCREVUS.
  • Talk with your healthcare provider about what birth control method is right for you during this time.

Pregnancy Registry. There is a pregnancy registry for women who take OCREVUS during pregnancy. If you become pregnant while receiving OCREVUS, tell your healthcare provider right away. Talk to your healthcare provider about registering with the OCREVUS Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby’s health.

Breastfeeding or plan to breastfeed? It is not known if OCREVUS passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take OCREVUS

OCREVUS can cause serious side effects, including:

Infusion reactions: Infusion reactions are a common side effect of OCREVUS, which can be serious and may require you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of OCREVUS for signs and symptoms of an infusion reaction.

Let our provider or nurse practitioner know if you get any of these symptoms:

  • Itchy skin
  • Trouble breathing
  • Nausea
  • Shortness of breath
  • Rash
  • Throat irritation or pain
  • Headache
  • Fatigue
  • Hives
  • Feeling faint
  • Swelling of the throat
  • Fast heart beat
  • Tiredness
  • Fever
  • Dizziness
  • Coughing or wheezing
  • Redness on your face (flushing)
  • These infusion reactions can happen for up to 24 hours after your infusion. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion. If you get infusion reactions, your healthcare provider may need to stop or slow down the rate of your infusion.

INFECTIONS:

OCREVUS increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Infections are a common side effect, which can be serious. Tell let the healthcare provider know if you have an infection or have any of the following signs of infection including fever, chills, or a cough that does not go away.

Signs of herpes infection include:

  • Cold sores
  • Genital sores
  • Pain
  • Shingles
  • Skin rash

Itching signs of a more serious herpes infection include:

  • Changes in vision
  • Severe or persistent headache
  • Confusion
  • Eye redness or eye pain
  • Stiff neck Signs of infection can happen during treatment or after you have received your last dose of OCREVUS.

Tell your healthcare provider right away if you have an infection. Your healthcare provider should delay your treatment with OCREVUS until your infection is gone.

Hepatitis b virus (hbv) reactivation:

Before starting treatment with OCREVUS, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with OCREVUS. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving OCREVUS.

Weakened immune system:

OCREVUS taken before or after other medicines that weaken the immune system could increase your risk of getting infections.

Progressive multifocal leukoencephalopathy (pml):

Progressive Multifocal Leukoencephalopathy (PML): PML is a rare brain infection that usually leads to death or severe disability, and has been reported with OCREVUS. Symptoms of PML get worse over days to weeks.

It is important that you call your healthcare provider right away if you have any new or worsening neurologic signs or symptoms that have lasted several days, including problems with:

  • Thinking
  • Eyesight
  • Strength
  • Balance
  • Weakness on 1 side of your body
  • Using your arms or legs

Decreased immunoglobulins:

OCREVUS may cause a decrease in some types of immunoglobulins. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.

What are the possible side effects of OCREVUS?

OCREVUS may cause serious side effects, including:

  • Risk of cancers (malignancies) including breast cancer. Follow your healthcare provider’s instructions about standard screening guidelines for breast cancer.
  • Inflammation of the colon, or colitis:

Tell your healthcare provider if you have any symptoms of colitis, such as:

  • Diarrhea (loose stools) or more frequent bowel movements than usual.
  • Stools that are black, tarry, sticky or have blood or mucus.
  • Severe stomach-area (abdomen) pain or tenderness.

What are the ingredients in ocrevus?

  • Active ingredient: ocrelizumab.
  • Inactive ingredients: glacial acetic acid, polysorbate 20, sodium acetate trihydrate, trehalose dihydrate.

How will i receive ocrevus?

  • OCREVUS is given through a needle placed in your vein (intravenous infusion) in your arm.
  • Before treatment with OCREVUS, your healthcare provider will give you a corticosteroid medicine and an antihistamine to help reduce infusion reactions (make them less frequent and less severe). You may also receive other medicines to help reduce infusion reactions. See “What is the most important information I should know about OCREVUS?”
  • Your first full dose of OCREVUS will be given as 2 separate infusions, 2 weeks apart. Each infusion will last about 2 hours and 30 minutes.
  • Your next doses of OCREVUS will be given as 1 infusion every 6 months. These infusions will last about 2 hours to 3 hours and 30 minutes depending on the infusion rate prescribed by your healthcare provider.
  • Ratio to receive infusions over approximately 3.5-hours or 2-hours, after appropriate premedication.

OCREVUS (ocrelizumab) injection is a preservative-free, sterile, clear or slightly opalescent, and colorless to pale brown solution supplied as a carton containing one 300 mg/10 mL (30 mg/mL) single-dose vial

Initial dose:

  • 300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusion.

Subsequent doses: single 600 mg intravenous infusion every 6 months.

QUTENZA® (capsaicin) 8% topical system is indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) or associated with diabetic peripheral neuropathy (DPN) of the feet.

Important safety information:

Do not dispense QUTENZA to patients for self‑administration or handling. Use only on dry, unbroken skin. Only physicians or healthcare professionals are to administer and handle QUTENZA, following the procedures in the label.

Warning and precautions:

  • Severe irritation: Whether applied directly or transferred accidentally from other surfaces, capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin to the healthcare professional, patients, and others. Do not use near eyes or mucous membranes, including face and scalp. Take protective measures, including wearing nitrile gloves and not touching items or surfaces that the patient may also touch. Flush irritated mucous membranes or eyes with water and provide supportive medical care for shortness of breath. Remove affected individuals from the vicinity of QUTENZA. Do not re‑expose affected individuals to QUTENZA if respiratory irritation worsens or does not resolve. If skin not intended to be treated comes into contact with QUTENZA, apply Cleansing Gel and then wipe off with dry gauze. Thoroughly clean all areas and items exposed to QUTENZA and dispose of properly. Because aerosolization of capsaicin can occur with rapid removal, administer QUTENZA in a well‑ventilated area, and remove gently and slowly, rolling the adhesive side inward.
  • Application-associated pain: Patients may experience substantial procedural pain and burning upon application and following removal of QUTENZA. Prepare to treat acute pain during and following application with local cooling (e.g., ice pack) and/or appropriate analgesic medication.
  • Increase in blood pressure: Transient increases in blood pressure may occur with QUTENZA treatment. Monitor blood pressure during and following treatment procedure and provide support for treatment‑related pain. Patients with unstable or poorly controlled hypertension, or a recent history of cardiovascular or cerebrovascular events, may be at an increased risk of adverse cardiovascular effects. Consider these factors prior to initiating QUTENZA treatment.
  • Sensory function: Reductions in sensory function (generally minor and temporary) have been reported following administration of QUTENZA. All patients with sensory deficits should be assessed for signs of sensory deterioration or loss prior to each application of QUTENZA. If sensory loss occurs, treatment should be reconsidered.
  • Adverse reactions: The most common adverse reactions (≥5% and > control group) in all controlled clinical trials are application site erythema, application site pain, and application site pruritus.

Qutenza has a favorable safety profile with no system drug interactions.

Treatment flexibility:

  • QUTENZA can be used alone or in combination

Low risk for systemic side effects:

  • QUTENZA is non-systemic
  • QUTENZA is non-opioid
  • QUTENZA has no contraindications

Low discontinuation rates:

  • 1% of QUTENZA patients discontinued in clinical studies due to an adverse event

VYEPTI is a prescription medicine used for the preventive treatment of migraine in adults. It is not known if VYEPTI is safe and effective in children. Eptinezumab-jjmr is a humanized immunoglobulin G1 (IgG1) monoclonal antibody specific for calcitonin gene-related peptide (CGRP) ligand. Eptinezumab-jjmr has an approximate molecular weight of 143 kD. Eptinezumab-jjmr is produced in pichia pastoris yeast cells by recombinant DNA technology. VYEPTI injection is a sterile, preservative-free, clear to slightly opalescent, colorless to brownish-yellow solution, for intravenous infusion.

What does vyepti contain?

Active ingredient: Eptinezumab-jjmr Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sorbitol, and Water for Injection. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Dosing and administration:

  • VYEPTI will be given by a healthcare provider in a healthcare setting.
  • Recommended dosage is 100 mg administered by intravenous (IV) infusion in your vein every 3 months. Some patients may benefit from a dosage of 300 mg administered by intravenous infusion every 3 months.
  • VYEPTI will be given over 30 minutes to an hour every 3 months. If you have questions about your infusion schedule, ask your healthcare provider.

Possible side effects:

VYEPTI may cause serious side effects, including: Allergic reactions. Allergic reactions can happen after receiving VYEPTI. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms of an allergic reaction such as;

  • Rash, swelling of your face, lips, tongue or throat.
  • Trouble breathing
  • Hives
  • Redness in your face
  • Stuffy nose
  • Scratchy throat

Contraindications:

VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients in VYEPTI. Reactions have included anaphylaxis and angioedema.

Hypersensitivity reactions:

  • Hypersensitivity reactions, including angioedema, urticaria, facial flushing, dyspnea, and rash, have occurred with VYEPTI in clinical trials and in the postmarketing setting. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity may occur. Cases of anaphylaxis have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI and institute appropriate therapy.

Adverse reactions:

  • The following clinically significant adverse reactions are described elsewhere in the labeling.
  • The most common adverse reactions (>2% and 2% or greater than placebo) were nasopharyngitis and hypersensitivity

Pregnancy: Before you receive VYEPTI, tell your healthcare provider about all of your medical conditions, including if you’re pregnant or plan to become pregnant.

  • It is not known if VYEPTI will harm your unborn baby.
  • Breastfeeding or plan to breastfeed? It is not known if VYEPTI passes into your breast milk.
  • There are no adequate data on developmental risks associated with the use of VYEPTI in pregnant women.

Lactation risk summary:

  • There are no data on the presence of eptinezumab-jjmr in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VYEPTI and any potential adverse effects on the breastfed infant from VYEPTI or from the underlying maternal conditions.

Pediatric use:

  • Safety and effectiveness in pediatric patients have not been established.

Geriatric use:

Clinical studies of VYEPTI did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. For additional information please visit https://www.vyepti.com/

LEQEMBI is a prescription medicine used to treat people with Alzheimer’s disease. It is not known if LEQEMBI is safe and effective in children.

Important safety information – What is the most important information I should know about LEQEMBI?

LEQEMBI can cause serious side effects including:

Amyloid Related Imaging Abnormalities or “ARIA”. ARIA is a side effect that does not usually cause any symptoms, but serious symptoms can occur. ARIA is most commonly seen as temporary swelling in areas of the brain that usually resolves over time. Some people may also have small spots of bleeding in or on the surface of the brain, and infrequently, larger areas of bleeding in the brain can occur. Most people with this type of swelling in the brain do not get symptoms, however, some people may have symptoms, such as:

  • Headaches
  • Confusion
  • Dizziness
  • Vision changes
  • Nausea
  • Difficulty walking
  • Seizures

Requirements: Prior to your infusion your healthcare provider will require you to do a Lumbar Puncture also known as a spinal tap, Positron emission tomography (PET) or a magnetic resonance imaging (MRI) scan before and during your treatment with LEQEMBI to check you for amyloid beta peptide. Some patients have a genetic risk factor (homozygous apolipoprotein E gene carriers) that may cause an increased risk for ARIA.

For additional information please visit https://www.leqembi.com

BRIUMVI is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Important safety information:

Contraindication: BRIUMVI is contraindicated in patients with:

  • Active HBV infection
  • A history of life-threatening infusion reaction to BRIUMVI

Warnings and precautions:

Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization.

Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.

Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved.

Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI.

Hepatitis B Virus (HBV) Reactivation:HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HBsAg and anti-HB tests. For patients who are negative for surface antigen [HBsAg] and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.

Progressive Multifocal Leukoencephalopathy (PML):Although no cases of PML have occurred in BRIUMVI-treated MS patients, JCV infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies.

If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.

MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.

If PML is confirmed, treatment with BRIUMVI should be discontinued.

Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines at least 4 weeks and, whenever possible at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.

Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.

Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. A pregnancy test is recommended in females of reproductive potential prior to each infusion. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.

Reduction in Immunoglobulins:As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.

Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections.

TYSABRI is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease

TYSABRI increases your risk of getting a rare brain infection—called progressive multifocal leukoencephalopathy (PML)—that usually leads to death or severe disability.

  • There is no known treatment, prevention, or cure for PML
  • You should not take certain medicines that weaken your immune system at the same time you are taking TYSABRI. Even if you use TYSABRI alone to treat your MS, you can still get PML
  • Your risk of getting PML is higher if you:

◊ Have been infected by the John Cunningham Virus (JCV). JCV is a common virus that can cause PML in people who have weakened immune systems, such as people taking TYSABRI. Before or while you receive TYSABRI, your doctor may do a blood test to check if you have been infected by JCV

◊ Have received TYSABRI for a long time, especially for longer than 2 years

◊ Have received certain medicines that can weaken your immune system before you start receiving TYSABRI

  • Your risk of getting PML is greatest if you have all 3 risk factors listed above. There may be other risk factors that have not yet been identified
  • Patients who are anti-JCV antibody negative are still at risk for the development of PML due to the potential for a new JCV infection or a false negative test result. Therefore, patients with a negative test result should be retested periodically
  • While you receive TYSABRI, and for 6 months after you stop receiving TYSABRI, it is important that you call your doctor right away if you have any new or worsening medical problems (such as problems with your thinking, eyesight, balance, or strength; weakness on 1 side of your body; and using your arms and legs) that have lasted several days. Tell all of your doctors that you are getting treatment with TYSABRI
  • Because of your risk of getting PML while you receive TYSABRI, TYSABRI is available only through a restricted distribution program called the TOUCH® Prescribing Program

Who should not receive TYSABRI?

Do not receive TYSABRI if you have PML or are allergic to natalizumab or any of the ingredients in TYSABRI.

What should I tell my doctor before receiving each dose of TYSABRI?

Before receiving TYSABRI, it is important to tell your doctor:

  • If you have a medical condition that can weaken your immune system, such as HIV infection or AIDS, leukemia or lymphoma, organ transplant, or others, or if you have any new or worsening medical problems that have lasted several days
  • If you are pregnant or plan to become pregnant. TYSABRI may cause low platelets, and in some cases also low red blood cells (anemia), in your newborn baby if you take TYSABRI while you are pregnant. It is not known if TYSABRI can cause birth defects
  • If you are breastfeeding or plan to breastfeed. TYSABRI can pass into your breast milk. It is not known if TYSABRI that passes into your breast milk can harm your baby. Talk to your doctor about the best way to feed your baby while you receive TYSABRI
  • About all of the medicines and supplements you take, especially medicines that can weaken your immune system. If you are not sure, ask your doctor

What are the possible side effects of TYSABRI?

TYSABRI can cause serious side effects. If you have any of the symptoms listed below, call your doctor right away:

  • Herpes infections. Increased risk of infection of the brain or the covering of your brain and spinal cord (encephalitis or meningitis) caused by herpes viruses that may lead to death. Symptoms include sudden fever, severe headache, or confusion. Infection of the eye caused by herpes viruses leading to blindness in some patients has occurred. Call your doctor if you have changes in vision, redness, or eye pain
  • Liver damage. Symptoms include yellowing of the skin and eyes (jaundice), unusual darkening of the urine, nausea, feeling tired or weak, or vomiting
  • Allergic reactions (e.g., hives, itching, trouble breathing, chest pain, dizziness, wheezing, chills, rash, nausea, flushing of skin, low blood pressure), including serious allergic reactions (e.g., anaphylaxis). Serious allergic reactions usually happen within 2 hours of the start of the infusion, but they can happen any time after receiving TYSABRI
  • Weakened immune system. TYSABRI may increase your risk of getting an unusual or serious infection
  • Low platelet counts. TYSABRI may cause the number of platelets in your blood to be reduced. Symptoms include easy bruising, small scattered spots on your skin that are red, pink or purple, heavier menstrual periods than are normal, bleeding from your gums or nose that is new or takes longer than usual to stop, or bleeding from a cut that is hard to stop

The most common side effects of TYSABRI are:

Headache, feeling tired, urinary tract infection, joint pain, lung infection, depression, pain in your arms or legs, diarrhea, vaginitis, rash, nose and throat infections, nausea, stomach area pain. If you experience any side effect that bothers you or does not go away, tell your doctor.

Methylprednisolone (methylprednisolone sodium succinate) also known as Solu-Medrol is part of a potent class of anti-inflammatory agents, known as corticosteroids. Corticosteroids are used to treat many inflammatory diseases. For example, the corticosteroid prednisone is commonly used to treat rheumatoid arthritis, lupus, vasculitis, dermatomyositis, MS, and many other conditions. Methylprednisolone is similar to prednisone but can be given at higher doses as an infusion into a vein (intravenous, IV) for treatment of severe inflammation.

If you have one of the relapsing-remitting forms of multiple sclerosis (MS), your healthcare provider may suggest a medication called Solu-Medrol, which is the liquid form of methylprednisolone. This is a powerful corticosteroid that’s given through a vein to make symptoms less severe and shorten MS relapses.

Solu-Medrol works by reducing the inflammation around lesions and closing the blood-brain barrier. This drug can be almost miraculously and swiftly effective.

Side Effects:

Methylprednisolone can cause short-term and long-term side effects. Side effects that can occur during or shortly after an infusion include blood-pressure changes, heart rate changes, irregular heart rate, electrolyte imbalances, elevated blood sugar, flushing of the skin, sweating, metallic taste, difficulty sleeping, mood or behavior changes, psychosis, seizures, increased susceptibility to infection, and anaphylaxis (serious allergic reaction).