Description
Zilucoplan injection is used to treat a nerve and muscle problem called myasthenia gravis in patients who are anti-acetylcholine receptor (AChR) antibody positive.
This medicine is available only under a restricted distribution program called the Zilbrysq® REMS (Risk Evaluation and Mitigation Strategy) Program.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of zilucoplan injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of zilucoplan injection in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Infection (eg, gonorrhea, influenza, pneumonia)—Use with caution. This medicine may decrease your body’s ability to fight infection.
- Meningococcal infection—Should not be given to patients with this condition.
- Pancreatitis (inflammation of the pancreas)—Use with caution. May make this condition worse.
Proper Use
This medicine is given as a shot under your skin in the stomach, thigh, or upper arm. It may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use this medicine.
It is very important that you understand the requirements of the Zilbrysq® REMS program, and become familiar with the Zilbrysq® medication guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide if you do not have one.
Make sure you have received a vaccine to prevent meningococcus infections at least 2 weeks before you receive this medicine. You may also be given antibiotic medicines to prevent infections if you are to receive this medicine right away. If you have already received the meningococcal vaccine in the past, your doctor will decide if you need another dose.
You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are red, bruised, swollen, or hard, or areas with scars or stretch marks.
To use the prefilled syringe:
- Allow 30 to 45 minutes for the medicine to warm up to room temperature. Do not warm it by using a heat source (eg, hot water, microwave, or direct sunlight) or in any other way.
- Wash your hands with soap and water before and after using this medicine.
- Check the liquid in the syringe. It should be clear and colorless. Do not use the medicine if it is cloudy, discolored, or has particles in it. Do not use the prefilled syringe if it has been cracked, leaking, or broken.
- Remove the needle cap. Hold the syringe with one hand and pull the needle cap straight off with your other hand.
- Do not touch or recap the needle. Do not remove any air bubbles.
- Pinch the skin around the injection site with one hand. Insert the needle into the skin at a 45 to 90 degree angle.
- Do not pull back on the plunger head. Do not touch the needle guard activation clips.
- Push the plunger head all the way down while holding onto the finger grip to inject all the medicine.
- Slowly release the plunger head by lifting your thumb. After injection, the needle guard will cover the needle and you may hear a click.
- Use a new needle and prefilled syringe each time you inject your medicine.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form (prefilled syringe):
- For myasthenia gravis:
- Adults—Dose is based on body weight and must be determined by your doctor.
- Weighing 77 kilograms (kg) or more—32.4 milligrams (mg) injected under the skin once a day.
- Weighing 56 to less than 77 kg—23 mg injected under the skin once a day.
- Weighing less than 56 kg—16.6 mg injected under the skin once a day.
- Children—Use and dose must be determined by your doctor.
- Adults—Dose is based on body weight and must be determined by your doctor.
- For myasthenia gravis:
Missed Dose
Call your doctor or pharmacist for instructions.
If you miss a dose, inject it as soon as possible. Then inject the next dose at your next scheduled time. Do not inject more than 1 dose each day.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
You may store the prefilled syringe at room temperature for up to 3 months. Do not put it back in the refrigerator. Throw the medicine away if not used within 3 months or if the expiration date has passed, whichever comes first.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
This medicine may increase your chance of having serious infections, including meningococcal infection, gonorrhea, influenza, or pneumonia. Avoid people who are sick or have infections. Tell your doctor right away if you have chest pain or tightness, chills, cough, diarrhea, drowsiness, fever, general feeling of discomfort or illness, headaches, joint pain, loss of appetite, muscle aches and pains, nausea, vomiting, fever, a stiff neck or back, rash, runny nose, shivering, sore throat, sweating, confusion, trouble sleeping, unusual tiredness or weakness, vomiting, or if your eyes have become sensitive to light.
Pancreatitis (inflammation of the pancreas) can occur with this medicine. Check with your doctor right away if you have bloating, chills, constipation, darkened urine, fast heartbeat, fever, indigestion, loss of appetite, nausea, pains in the stomach, side, or abdomen, possibly radiating to the back, vomiting, or yellow eyes or skin.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Bladder pain
- bloody or cloudy urine
- body aches or pain
- chills
- cough
- difficulty, burning, or painful urination
- ear congestion
- fever
- frequent urge to urinate
- headache
- loss of voice
- lower back or side pain
- sneezing
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
Incidence not known
- Boating
- chest pain or tightness
- confusion
- constipation
- darkened urine
- diarrhea
- drowsiness
- fast heartbeat
- general feeling of illness
- indigestion
- joint pain
- loss of appetite
- muscle aches and pains
- nausea
- pains in the stomach, side, or abdomen, possibly radiating to the back
- shivering
- stiff neck or back
- sweating
- trouble breathing
- trouble sleeping
- vomiting
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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