Zilucoplan 32.4 Mg/0.81 Ml Subcutaneous Syringe

GENERIC NAME(S): Zilucoplan

OTHER NAME(S): Zilucoplan Syringe

WARNINGS:

Zilucoplan can lower your body's ability to fight infections. It can increase your chance of getting a very serious (possibly fatal) brain/spinal cord infection (meningitis). Get medical help right away if you develop any signs of a severe infection (including meningitis), such as nausea/vomiting that doesn't stop, high fever, chills, severe headache, stiff neck, mental/mood changes (such as confusion), muscle aches with flu-like symptoms, eye sensitivity to light.

You should get the vaccine for meningitis (meningococcal vaccine) at least 2 weeks before you start zilucoplan. If you have been previously vaccinated for meningitis, ask your doctor if you need to be vaccinated again before using this medication. The vaccine will protect most people, but meningitis may occur even in people who have been vaccinated. You should still watch for signs of meningitis even if you receive the vaccine. Consult your doctor for more details.

To receive this medication in the United States, you must understand, agree to, and carefully follow the requirements of the Zilbrysq REMS Program. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Who should not take Zilucoplan 32.4 Mg/0.81 Ml Subcutaneous Syringe?

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Uses

Uses

Zilucoplan is used to treat a certain muscle condition (generalized myasthenia gravis). It may help to improve symptoms of muscle weakness.

How to use Zilucoplan 32.4 Mg/0.81 Ml Subcutaneous Syringe

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using zilucoplan and each time you get a refill. Carry the Patient Safety Card with you at all times during treatment and for 2 months after your last dose of zilucoplan. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin in the abdomen, thigh, or upper arm as directed by your doctor, usually once daily. The dosage is based on your medical condition and weight.

If stored in the refrigerator, remove this medication from the refrigerator and leave at room temperature for 30 to 45 minutes before use. Do not warm up this medication in any other way such as heating in the microwave, placing in hot water, or leaving it in direct sunlight. 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 in an area that is tender, bruised, red, hard, or has scars or stretch marks. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

Do not use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

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

Side Effects

Side Effects

See also Warning section.

Pain/swelling/bruising at the injection site or diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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: signs of infection (such as cough/sore throat that doesn't go away, fever, painful urination), stomach/abdominal pain.

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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Precautions

Before using zilucoplan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/recent infection.

Zilucoplan can make you more likely to get certain infections (such as gonorrhea, meningitis). Talk to your doctor for more details.

Tell your doctor your vaccine history and ask if you need to get any vaccines before starting treatment with this medication. Tell your health care professional that you are using zilucoplan before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

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 medication passes into breast milk. Consult your doctor before breastfeeding.

Interactions

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as amylase/lipase level) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember on the same day. Use your next dose at the regular time. Do not give more than 1 dose per day to catch up.

Storage

Store in the original carton in the refrigerator away from light. Do not freeze. This medication may also be stored in the original carton at room temperature for up to 3 months. If stored at room temperature, do not put it back in the refrigerator. Throw away this medication if it has been stored at room temperature for longer than 3 months.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised January 2024. Copyright(c) 2024 First Databank, Inc.

Images

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.