Daclizumab, Injection

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KEY POINTS

• This medicine is given by injection to treat relapsing forms of multiple sclerosis. Use it exactly as directed.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause serious liver problems or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: interleukin-2 receptor blocking antibody

Generic and brand names: daclizumab, injection; Zinbryta

What is this medicine used for?

This medicine is given by injection to treat relapsing forms of multiple sclerosis to slow the progression of the disease. You must be enrolled in a special program before you can receive this medicine. Carry the patient wallet card with you at all times. Talk with your healthcare provider about this.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to human albumin
• A blockage in the intestines, Crohn’s disease, or ulcerative colitis
• An autoimmune disease such as lupus, psoriasis, or rheumatoid arthritis
• Depression, anxiety, or other mental health problem
• Liver disease
• Skin problems such as eczema or psoriasis
• Tuberculosis

Tell your healthcare provider if you have recently had an injection. Also, tell your healthcare provider if you are scheduled to have any vaccines. Ask your healthcare provider if you should have any vaccines before you start treatment with this medicine.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Often you can give yourself these shots or have someone at home give them to you. Check the label on the medicine for directions about your specific dose. Be sure you know how and when to have them and how much medicine to use. Change your injection site each time you inject the medicine, following your healthcare provider's instructions.

Check with your healthcare provider before using this medicine in children under age 18.

This medicine is given by subcutaneous injection (shot just under the skin). It is usually given once per month. The medicine comes in a prefilled syringe with a needle already attached to it. If you are not sure of how to give yourself the shots, ask your healthcare provider or pharmacist for help.

Take this medicine exactly as your healthcare provider prescribes. Do not take more or less than prescribed. Do not stop taking this medicine without your healthcare provider's approval.

What if I miss a dose?

If you miss a dose, inject the next dose as soon as possible within 2 weeks of the missed dose. If more than 2 weeks after your missed dose, skip the missed dose and take the next dose on your regular schedule the next month. Do not inject more than 1 dose of this medicine at a time. If you are not sure of what to do if you miss a dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose have not been reported.

What should I watch out for?

If you feel depressed or have thoughts of suicide, contact your healthcare provider right away.

This medicine may cause life-threatening liver problems. If you develop nausea, vomiting, dark urine, stomach pain, unexplained loss of appetite, yellowing of your eyes or skin, or severe fatigue, contact your healthcare provider right away. These may be signs of liver damage. Alcohol may increase the risk of liver problems. Do not drink alcohol while taking this medicine unless your healthcare provider approves.

This medicine may cause serious immune system problems involving your skin, lymph nodes, intestines, or other parts of your body. Talk with your healthcare provider about this.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first. Some vaccines should not be given for up to 4 months after you stop treatment with this medicine.

You need regular lab tests to see how this medicine is affecting you during treatment and for 6 months after you stop treatment. Keep all appointments for these tests.

This medicine may cause redness, pain, or swelling at the injection site. If these symptoms don’t go away or get worse, contact your healthcare provider.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): New or worsening depression or thoughts of suicide; unusual mood changes; confusion or unusual thoughts or behavior; seizures; unusual bruising or bleeding; yellowing of the skin or eyes; dark urine; light-colored bowel movements; severe stomach pain, nausea, or vomiting; swelling of the fingers, ankles, or feet; trouble breathing or shortness of breath; unusual tiredness or weakness; painful urination; bloody urine or bowel movements; severe or ongoing diarrhea; unexplained fever, cough, or sore throat; painful, or swollen lymph nodes; skin rash or irritation.

Other: Mild irritation at the spot where the shot is given.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Acetaminophen and medicines that contain acetaminophen
• Allopurinol (Aloprim, Zyloprim)
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone; Pacerone), dronedarone (Multaq), propafenone (Rythmol), and quinidine
• Antibiotics such as amoxicillin (Amoxil, Moxatag), amoxicillin/clavulanate potassium (Augmentin), azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), chloramphenicol, ciprofloxacin (Cipro), clarithromycin (Biaxin), doxycycline (Doryx, Monodox, Vibramycin), erythromycin (E.E.S., Ery-Tab, Erythrocin), isoniazid, levofloxacin (Levaquin), moxifloxacin (Avelox), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), sulfamethoxazole/trimethoprim (Bactrim, Septra), telithromycin (Ketek), tetracycline, and trimethoprim (Primsol)
• Antifungal medicines such as fluconazole (Diflucan), isavuconazonium (Cresemba), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), terbinafine (Lamisil), and voriconazole (Vfend)
• Antipsychotic medicines such as chlorpromazine, prochlorperazine (Compro), risperidone (Risperdal), thioridazine, and trifluoperazine
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), lamotrigine (Lamictal), phenytoin (Dilantin, Phenytek), primidone (Mysoline), and valproic acid (Depacon, Depakene, Depakote)
• Cancer medicines such as abiraterone (Zytiga), axitinib (Inlyta), bortezomib (Velcade), bosutinib (Bosulif), crizotinib (Xalkori), flutamide (Eulexin), imatinib (Gleevec), lapatinib (Tykerb), nilotinib (Tasigna), sorafenib (Nexavar), sunitinib (Sutent), tamoxifen, vandetanib (Caprelsa), vemurafenib (Zelboraf), and vincristine (Marqibo)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), cholestyramine (Prevalite), colestipol (Colestid), ezetimibe (Zetia), ezetimibe/simvastatin (Vytorin), fenofibrate (Antara, Fenoglide, Lipofen, TriCor, Triglide), fluvastatin (Lescol), gemfibrozil (Lopid), lovastatin (Altoprev), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Disulfiram (Antabuse)
• Fingolimod (Gilenya)
• HIV medicines such as atazanavir (Reyataz), delavirdine (Rescriptor), didanosine (Videx), efavirenz (Sustiva), efavirenz/emtricitabine/tenofovir (Atripla), emtricitabine (Emtriva), emtricitabine/rilpivirine/tenofovir (Complera, Odefsey), etravirine (Intelence), lamivudine (Epivir, Epivir-HBV), nevirapine (Viramune), rilpivirine (Edurant), stavudine (Zerit), and zidovudine (Retrovir)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings, and hormones such as conjugated estrogens (Premarin), estradiol (Climara, Estrace, Estraderm, Vivelle), and norethindrone (Aygestin, Micronor) (Talk to your healthcare provider if you need birth control.)
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), clopidogrel (Plavix), dabigatran (Pradaxa), dalteparin (Fragmin), dipyridamole (Persantine), enoxaparin (Lovenox), heparin, rivaroxaban (Xarelto), and vorapaxar (Zontivity)
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as leflunomide (Arava), and tofacitinib (Xeljanz)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Natalizumab (Tysabri)
• Natural remedies such as echinacea and kava
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Propylthiouracil

Do not have any vaccinations with live virus vaccines unless your healthcare provider approves. Do not drink alcohol while taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Keep this medicine refrigerated. Protect it from heat, high humidity, and bright light. Do not let it freeze. Allow the syringe to warm to room temperature (about 30 minutes) before injection. Do not use hot water to warm the syringe. Do not put the medicine back into the refrigerator after it is at room temperature. Discard after 30 days without refrigeration.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.