Daclizumab

By

Generic Name: Daclizumab Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: N

Uses

What is Daclizumab used for?

Daclizumab is used to treat a certain type of multiple sclerosis (relapsing multiple sclerosis-MS). Daclizumab belongs to a class of medications known as monoclonal antibodies. It is not a cure for MS but is thought to help by preventing your immune system from attacking the nerves in your brain and spinal cord. It helps decrease the number of episodes of worsening and may prevent or delay disability.

This drug is being withdrawn from the worldwide market due to risks outweighing benefits.

How should I take Daclizumab?

This drug is given by injection under the skin of the thigh, abdomen, or upper arm as directed by your doctor, usually once a month. Learn all preparation and usage instructions in the product package.

Remove this medication from the refrigerator and leave it at room temperature for 30 minutes before injecting. Do not warm up this medication any other way such as by heating in the microwave or placing in hot water.

Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into any areas of skin that are irritated, tender, red, bruised, infected, scarred, or tattooed.

Use this medication regularly to get the most benefit from it. To help you remember, mark the day on the calendar when you need to receive the medication.

Learn how to store and discard medical supplies safely. Never reuse syringes or needles. Consult your pharmacist.

Tell your doctor if your condition does not get better or if it gets worse.

How do I store Daclizumab?

Store daclizumab in the original carton in a refrigerator. Protect from heat and light. Do not freeze daclizumab, and do not use the medicine if it does freeze. Before injecting your dose, take one vial out of the refrigerator and allow it to reach room temperature for 30 minutes. Do not heat the medicine in a microwave or with hot water. Do not put the vial back into the refrigerator after leaving it at room temperature. Do not use daclizumab if it looks cloudy or has particles in it. Call your pharmacist for new medication.

Daclizumab may be stored in the original carton at room temperature for up to 30 days. Once the medicine has reached room temperature, you should not put it back into the refrigerator.

Each single-use prefilled syringe or injection pen is for one use only. Throw away after one use, even if there is still some medicine left inside.

There may be different brands of Daclizumab that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Daclizumab down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Daclizumab?

Before using this medication, tell your doctor or pharmacist your medical history, especially of: past/current/returning infections (including fungal, hepatitis B, tuberculosis), liver problems, mental/mood problems, skin problems (such as eczema, psoriasis).

Daclizumab can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Daclizumab during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Daclizumab. Daclizumab is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Daclizumab?

Cold symptoms (such as stuffy/runny nose), pain/swelling in your nose/throat/mouth, or red, dry, itchy, scaly skin may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: pale skin, shortness of breath.

Get medical help right away if you have any very serious side effects, including: seizure, mental/mood changes (including depression or thoughts of suicide), problems with speech or coordination, unusual tiredness.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infections (such as sore throat that doesn’t go away, fever, chills).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Daclizumab?

Daclizumab may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Daclizumab?

Daclizumab may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Daclizumab?

Daclizumab may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Daclizumab.

What is the dose of Daclizumab for an adult?

Usual Adult Dose for Multiple Sclerosis

17 years and older:

150 mcg subcutaneously once a month

Comments:

-Sites for injection are the thigh, abdomen, and back of the upper arm.

-If a dose is missed within 2 weeks of the scheduled dose, it should be given immediately and the original monthly dosing schedule should be resumed.

-If a dose is missed and it is more than 2 weeks from the scheduled dose, the missed dose should be skipped and the original monthly dosing schedule should be resumed.

-Only one dose should be administered at one time.

Use: For the treatment of adult patients with relapsing forms of multiple sclerosis (MS) who have had an inadequate response to 2 or more drugs

Liver Dose Adjustments

-Preexisting hepatic impairment (including ALT or AST at least 2 times the ULN): Contraindicated

-A history of autoimmune hepatitis or other autoimmune condition involving the liver: Contraindicated

-Clinical trials did not include patients with ALT or AST more than 2 times the ULN.

What is the dose of Daclizumab for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Daclizumab available?

Daclizumab is available in the following dosage forms and strengths:

  • Intravenous solution,
  • Subcutaneous solution.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Daclizumab, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: August 29, 2018 | Last Modified: August 29, 2018

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