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Pegcetacoplan

Generic Name: Pegcetacoplan [peg-SET-aKOE-plan] [peg-SET-a-KOE-plan]
Name of the Brand: Empaveli
Dosage Form: Subcutaneous solution (1080 mg/20 mL)
Drug Class: Selective immunosuppressants

What is Pegcetacoplan?

Pegcetacoplan helps treat paroxysmal hemoglobinuria nocturnal (PNH) in adults.

Pegcetacoplan is only available under an exclusive program. It is necessary to be enrolled in the program and be aware of the benefits and risks of pegcetacoplan.Pegcetacoplan is also used for reasons not mentioned in this medication guide.

Side effects of Pegcetacoplan

See a doctor immediately. If you are experiencing symptoms that are warning signs of a reaction, such as difficulty breathing, hives, or swelling of your lips, face, and tongue,

There are some side effects that can happen when you receive the infusion. Inform your doctor if you feel faint or if you are experiencing chest pain, breathing problems, or swelling of your face.

Consult your physician immediately if you show symptoms of infection, such as:

  • Muscular pain associated with symptoms of flu-like signs (fever, chills);
  • A fever and red rash as well as a headache;
  • Headache that is accompanied by nausea and vomiting, as well as stiffness or pain in the back or neck;
  • Clammy skin;
  • Extreme pain;
  • Quick pulses; breathing problems;
  • Confusion
  • Your eyes might become more sensitive to the light.

If you stop taking pegcetacoplan and consult your physician in case you notice any new or more severe symptoms, including: nausea, fatigue, confusion, discomfort, trouble swallowing, breathing, or urinating (in men), trouble getting an erection, chest pain, discomfort in one leg or arm, or numbness or weakness in one part of your body,

Common adverse consequences of pegcetacoplan could include:

  • Stomach pain, vomiting, and diarrhea;
  • Sores that are cold;
  • Symptoms of a cold like nasal stuffiness, sneezing, an inflamed throat, and a cough;
  • Tiredness;
  • Discomfort, itching, burning, redness, swelling, bleeding, swelling, or a lump of hard tissue in the area where the medication was injected.

This isn't a complete list of possible side effects, and other side effects could be present. Contact your doctor to seek medical advice on adverse effects. You can report adverse reactions to the FDA at 1-800-FDA-1088.

Warnings

It is possible to contract infections more frequently and even severe or fatal illnesses. Call your doctor when you experience symptoms of flu or fever such as headache, muscle pain, anxiety, back or neck stiffness, vomiting, or a rash, or if your eyes are susceptible to the light.You'll need certain vaccinations prior to starting to use pegcetacoplan.

Take a look at your patient safety card for information about serious diseases and the signs to look out for. Keep the card in your pocket throughout the time you are using pegcetacoplan, for at least two months following your last dose. The risk of infection can persist for a few weeks after you stop taking pegcetacoplan.

Before you take this drug

It is not recommended to treat with pegcetacoplan if you are sensitive to the ingredient or if you are suffering from a serious infection (such as pneumonia, meningitis, or influenza type B) orhave not been vaccinated for these illnesses (unless the potential risks of delaying treatment outweigh the risk of contracting infections).

A minimum of 2 weeks prior to the time you begin using pegcetacoplan, you'll require vaccinations to guard against meningococcal infections, pneumonia, and influenza B (Hib). Even if you've had these vaccines previously, they may be required once more.If you are required to start receiving pegcetacoplan prior to being vaccine-free, you might receive antibiotic medication to use in the first two weeks of treatment with pegcetacoplan.Inform your doctor if you have experienced any signs of an infection (fever, chills, a fever, or flu symptoms).

could harm an infant. You may need an ultrasound test to be sure that you're not pregnant. Utilize contraceptives when you are taking pegcetacoplan for up to 40 days following the last dose. Inform your doctor if you are pregnant.Avoid breastfeeding during the course of this medication and for a minimum of 40 days following your last dose.Not permitted for use by anyone under 18.

How to take Pegcetacoplan?

Follow all instructions on the prescription label and go through all medication guides or instruction sheets. Follow the medication precisely as directed.If you've used a different medication called eculizumab (Ultomiris), it is recommended to wait 4 weeks following the final dose of eculizumab prior to commencing the treatment using pegcetacoplan.If you've been taking another medication known as Eculizumab (Soliris), continue to take it for a period of 4 weeks after the initial dose and end the eculizumab.

Pegcetacoplan is injected beneath the skin using an infusion pump, typically twice a week or at least once every three days. It is possible to inject this medication yourself.Take note of all the instructions for use. Consult your physician or pharmacist for assistance.Make an injection at the time you're able to administer it. Inform your pharmacist if medicine appears cloudy, has changed color, or has particles.

Don't reuse needles or syringes. Put them in an impervious to puncture "sharps" container and dispose of them in accordance with the laws of your state or municipality. Be sure to keep it out of range of children and pets.

There is a chance that you will contract infections more often, or even fatal infections. You'll need regular medical tests.Pegcetacoplan has long-lasting consequences for your body, even after you have stopped using this medication. If you suffer from PNH and you cease using pegcetacoplan, your physician might want to monitor your improvement for a minimum of 8 weeks after the last dose.

Take a look at your patient safety card for information about serious illnesses and the signs to be aware of. Keep the card handy whenever you use pegcetacoplan for a minimum of two months after the last dose. The risk of infection could persist for a few weeks after you stop taking pegcetacoplan.

This medication can alter the results of tests for medical conditions. Inform any physician who treats you that you're taking pegcetacoplan.Keep vials in the refrigerator in the original carton to guard against light. Avoid using expired pegcetacoplan.

Details on dosage

Usual Adult Dose for Paroxysmal Nocturnal Hemoglobinuria:

Subcutaneous: 1 080 mg two times each week, infused via an infusion pump that is commercially available with a reservoir of no less than 20 milliliters.
To lower the risk of hemolysis resulting from abrupt withdrawal of treatment after switching to C5 inhibitors:
If you are a patient who is switching from eculizumab, begin this medication with eculizumab at its current dosage. Within 4 weeks, stop eculizumab prior to continuing monotherapy with this drug.
For patients who are switching to eculizumab, begin this medication no more than 4 weeks following the last dose of eculizumab.
Comments:
Vaccinate against encapsulated bacteria such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae Type B for at least two weeks before starting treatment as per the current ACIP guidelines.
It is recommended to give two weeks of antibacterial drug prophylaxis in the event that this drug needs to be taken immediately and if vaccines are administered no more than two weeks prior to starting treatment.
Use: To treat adult patients suffering from hemoglobinuria that is paroxysmal and nocturnal (PNH).

What happens If I miss a dose?

Use the medication as soon as you are able; however be sure to take a break from the missed doses when you're nearing when you'll need to take your next dose.Don't take two doses at once.

What happens if I overdose?

Get medical attention in an emergency or contact the poison help line at 1-800-222-1222.

What should be avoided?

Beware of injecting on skin that's damaged, red, soft, hard, damaged, or irritated. Avoid injecting pegcetacoplan into areas of skin that have stretch marks, scars, or tattoos.

Interaction with other drugs

Other drugs can interact with pegcetacoplan. This covers prescription as well as non-prescription supplements, medicines, as well as herbal supplements. Discuss with your physician all other medications you take.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*

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