Zinbryta

Zinbryta is a prescription medication used to treat relapsing forms of multiple sclerosis.

It belongs to a group of drugs called interleukin blockers. These work by blocking the action of a protein involved with the body’s inflammatory response. 

It is available as a long-acting injection and is administered under the skin (subcutaneously), once-a-month.  

Common side effects of Zinbryta include cold symptoms, upper respiratory tract infection, and rash.

Zinbryta is a prescription medication used to treat relapsing forms of multiple sclerosis (MS). It will not cure MS but may decrease the number of flare ups and slow the occurrence of some of the disabilities that are common in people with MS. Because of its safety profile, the use of Zinbryta should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Zinbryta for the treatment of multiple sclerosis is 150 mg injected subcutaneously once monthly.

WARNING: HEPATIC INJURY INCLUDING AUTOIMMUNE HEPATITIS and OTHER IMMUNE-MEDIATED DISORDERS

Hepatic Injury Including Autoimmune Hepatitis

• Zinbryta can cause severe liver injury including life-threatening events, liver failure, and autoimmune hepatitis. Obtain transaminase and bilirubin levels before initiation of Zinbryta. Monitor and evaluate transaminase and bilirubin levels monthly and up to 6 months after the last dose.
• Zinbryta is contraindicated in patients with pre-existing hepatic disease or hepatic impairment.

Other Immune-Mediated Disorders

• Immune-mediated disorders including skin reactions, lymphadenopathy, non-infectious colitis, and other immune-mediated disorders can occur with Zinbryta.

These conditions may require treatment with systemic corticosteroids or immunosuppressive medication.

Zinbryta is available only through a restricted distribution program called the Zinbryta REMS Program.

Zinbryta can cause serious side effects, including:

• Liver problems. Zinbryta may cause serious liver problems (including autoimmune-related liver problems) that may lead to death. Your healthcare provider should do blood tests to check your liver before you start using Zinbryta, every month while you are using Zinbryta, and monthly for 6 months after you stop using Zinbryta. Your healthcare provider should check your test results before your next dose. Call your healthcare provider right away if you have any of the following symptoms of liver problems:
  • nausea or vomiting
  • stomach pain
  • unusual tiredness
  • not wanting to eat
  • yellowing of the skin or whites of your eyes
  • dark urine
• Immune system problems. Some people using Zinbryta develop immune-mediated disorders (a condition where the body’s immune system attacks healthy cells in their body) and other immune system problems. Call your healthcare provider right away if you have any of the following symptoms:
  • skin reactions such as rash or skin irritation
  • tender, painful, or swollen lymph nodes
  • symptoms of low red blood cell counts, which can include looking very pale, feeling more tired than usual, dark urine 
  • intestinal problems (colitis). Symptoms can include fever, stomach pain, blood in your stools, or diarrhea that does not go away
  • any new and unexplained symptoms affecting any part of your body

Because of the risk of serious liver problems (including autoimmune-related liver problems) and other immune system problems, Zinbryta is only available through a restricted program called the Zinbryta Risk Evaluation and Mitigation (REMS) Program.

• Before you begin using Zinbryta, you must enroll in the Zinbryta REMS Program. Talk to your healthcare provider about how to enroll in the Zinbryta REMS Program.
• Zinbryta can only be given at a certified pharmacy that participates in the Zinbryta REMS Program. Your healthcare provider can give you information on how to find a certified pharmacy.
• Your healthcare provider or pharmacist will give you a Zinbryta Patient Wallet Card along with this Medication Guide. It has important information about Zinbryta and should be carried with you at all times. Show the Zinbryta Patient Wallet Card to all of your healthcare providers so that they know you are being treated with Zinbryta.

Do not take Zinbryta if you:

• are allergic to Zinbryta or to any of its ingredients
• have pre-existing hepatic disease or hepatic impairment, including ALT or AST at least 2 times the ULN, because Zinbryta could exacerbate existing liver dysfunction
• have a history of autoimmune hepatitis or other autoimmune condition involving the liver

Serious side effects have been reported with Zinbryta. See the “Zinbryta Precautions” section.

Common side effects of Zinbryta include the following:

• upper respiratory tract infection
• flu
• pain or swelling in your nose, throat, or mouth
• bronchitis
• abnormal liver function tests
• dry, itchy, scaly, or inflamed skin (eczema)
• rash
• depression and depressed mood
• swollen lymph glands

This is not a complete list of Zinbryta side effects. Ask your doctor or pharmacist for more information.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
 

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take hepatotoxic drugs such as:

• acetaminophen (Tylenol)
• isonaizid (Nydrazid)
• ketoconazole (Nizoral)
• fluconazole (Diflucan)
• antiretrovirals
  • efavirenz/emtricitabine/tenofovir (Atripla)
  • rilpivirine (Edurant)
  • emtricitabine (Emtriva)
  • elvitegravir, cobicistat, emtricitabine, and tenofovir (Stribild)
  • tenofovir and emtricitabine (Truvada)
  • tenofovir (Viread)
  • adefovir (Hepsera)
• aspirin and other NSAIDs (nonsteroidal anti-inflammatory drugs) such as
  • celecoxib (Celebrex)
  • diclofenac (Cambia, Cataflam, Flector, Voltaren, Zipsor and others)
  • etodolac (Lodine)
  • ibuprofen (Advil, Motrin, Nuprin)
  • indomethacin (Indocin, Indocin SR)
  • ketoprofen (Orudis, Actron, Oruvail)
  • ketorolac (Toradol)
  • meloxicam (Mobic)
  • nabumetone (Relafen)
  • naproxen (Naprosyn)
  • naproxen sodium (Aleve, Anaprox, Naprelan)
  • oxaprozin (Daypro)
  • piroxicam (Feldene)

Caution should be used when using hepatotoxic drugs, including non-prescription products, concomitantly with Zinbryta. Carefully consider the need for the use of herbal products or dietary supplements that can cause hepatotoxicity.

This is not a complete list of Zinbryta drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Zinbryta crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with the use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Zinbryta.