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Daclizumab Injection

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WARNING

Daclizumab may seriously or fatally harm the liver. Those who already have liver disease and those taking other drugs that are known to cause liver damage are at an increased risk of developing liver damage. If you have or have previously had hepatitis or liver issues, let your doctor know. You could be advised by your doctor not to use daclizumab injection. Inform your doctor and chemist about all of the medications you are taking so they can determine whether any of them could make you more likely to experience liver damage while receiving therapy with daclizumab. Throughout and for six months following your daclizumab treatment, your doctor will keep an eye out for any indications of liver issues. Call your doctor right away if you have any of the following symptoms: gastrointestinal discomfort in the upper right portion, vomiting, unusual bruising or bleeding, excessive exhaustion, lack of energy, appetite loss, yellowing of the skin or eyes, dark urine, or flu-like symptoms.

Serious immune system abnormalities could be caused by daclizumab (conditions that occur when the immune system attacks healthy cells in the body). Inform your doctor if you now have or have ever had eczema or psoriasis. Call your doctor right away if you have any of the following symptoms: Any new, unexplained symptom affecting any region of your body, including redness, itching, or scaling of the skin, enlarged glands in the neck, armpits, or groyne, diarrhoea, bloody stools, stomach pain, or any other symptom.

Daclizumab injection is only accessible through an unique restricted distribution programme due to the hazards associated with this medicine. The Zinbryta Risk Evaluation and Mitigation Strategies (REMS) Program has been established by the daclizumab producer to ensure that patients do not take daclizumab injection without the required monitoring. You must register with the Zinbryta REMS programme along with your physician and chemist. For additional information about this programme and how you will receive your medication, speak with your doctor.

Keep all of your appointments with your physician and the lab. Before, during, and for six months following your final dosage, your doctor will request specific tests to monitor your body’s reaction to the daclizumab injection.

The patient information sheet (Medication Guide) from the manufacturer will be sent to you by your doctor or chemist when you start treatment with daclizumab injection and at each time you get a new prescription. If you have any questions, carefully read the information and ask your doctor or chemist. The Medication Guide is also available on the Food and Drug Administration (FDA) website at http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

Discuss the potential risks of receiving a daclizumab injection with your doctor.

Why is this medication prescribed?

People who have relapsing-remitting forms of multiple sclerosis, which is a disease where symptoms occasionally flare up, can use daclizumab to stop symptom episodes and slow the worsening of disability (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control). Those who have tried at least two different MS drugs without success typically turn to daclizumab. Immunomodulators are a group of drugs that includes daclizumab. It is supposed to function by reducing inflammation and the immune cells’ ability to operate in a way that could harm the nerves.

How should this medicine be used?

For subcutaneous injection, daclizumab is available as a solution (liquid) in a prefilled syringe (under the skin). Typically, it is injected once each month. Ask your doctor or chemist to explain any instructions on your prescription label that you are unsure about following. Daclizumab should only be used as prescribed. Use it only as directed by your doctor, neither more nor less often.

Your doctor’s office will be where you receive your first dosage of daclizumab. After that, you can administer daclizumab yourself or with the help of a friend or relative. Read the included written directions before using daclizumab for the first time. To learn how to inject a drug, ask your doctor or chemist to demonstrate it to you or the person doing the injecting.

Daclizumab can be injected into the thighs, stomach, or backs of the upper arms. If your skin is inflamed, bruised, reddish, infected, scarred, or tattooed, avoid injecting your medication there.

Never use a prefilled syringe or reuse a needle that has already been used. Used syringes should be disposed of in a container that won’t puncture. How to get rid of the puncture-resistant container should be discussed with your doctor or chemist.

Other uses for this medicine

Ask your doctor or chemist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before using daclizumab injection,

  • If you have an allergy to daclizumab, any other medications, or any of the chemicals in daclizumab injection, let your doctor and chemist know right once. For a list of the ingredients, consult the Medication Guide or speak with your chemist.
  • Inform your doctor and chemist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • If you have an illness or have ever had tuberculosis, let your doctor know. Tell your doctor if you have ever thought about or tried suicide, or if you suffer from depression now or in the past.
  • Inform your doctor if you are expecting, intend to get pregnant, or are nursing a baby. Call your doctor if you conceive while taking daclizumab.
  • You should be aware that while on daclizumab injection, you could have depression or suicidal thoughts, including planning or actually trying to harm or kill yourself. If you encounter any of the following symptoms, you, your family, or your carer should call your doctor right away: new or worsening depression, talking or thinking about wanting to kill yourself or end your life, or any other unexpected changes in behaviour or mood. Make sure your family or carer is aware of any symptoms that could be significant so they can contact the doctor on your behalf if you are unable to call for help.
  • Do not get any shots without consulting your doctor while you are receiving daclizumab treatment or for up to 4 months after your final dosage.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you forget to take a dosage of daclizumab injection, administer it as soon as you remember. If it has been more than two weeks after your missed dosage, skip it and carry on with your regular dosing regimen. To make up for a missing dose, avoid injecting a second dose. If you forget to take a dose and have concerns, call your doctor.

What side effects can this medication cause?

Side effects from daclizumab injection are possible. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Acne
  • Mouth ache

Some adverse effects may be severe. If you notice any of these signs or any of the ones in the IMPORTANT WARNING section, call your doctor right away or seek emergency medical attention.

  • Rash
  • Hives
  • Itching
  • Breathing or swallowing challenges
  • Enlargement of the throat, lips, tongue, eyes, or face
  • Increasing or fresh depression
  • Alterations in behaviour or mood
  • Considering, planning, or attempting to injure or kill oneself
  • Illness symptoms such a runny nose, coughing, sore throat, fever, chills, and others
  • Having trouble urinating
  • Difficulty urinating
  • Seizures

Further negative effects of daclizumab could exist. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly packed in the carton it was packaged in and out of the reach of children. Do not freeze daclizumab; instead, keep it in the refrigerator. This syringe needs to be thrown away if the medication gets accidently frozen. Daclizumab should be kept away from light and can be stored at room temperature for up to 30 days. Once daclizumab has been kept at room temperature, it shouldn’t be put back in the fridge.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your chemist or the garbage/recycling agency in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at http://goo.gl/c4Rm4p for additional information.

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Inform the lab staff and your doctor that you are using daclizumab injection prior to any laboratory test.

No one else should take your medication. Any queries you may have regarding prescription refills should be directed to your chemist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Zinbryta®
  • Zenapax®
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