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Name of the generic: pegcetacoplan
Dosage form: injection, for subcutaneous use
Drug class: selective immunosuppressants

What is Empaveli?

Empaveli is a prescription medication that is used to treat adults suffering from the condition known as paroxysmal nighttime hemoglobinuria (PNH).

It isn't known whether Empaveli is secure and effective for children.

Important information

Empaveli is a drug that can impact the immune system. Empaveli could reduce the capacity of your immune system to fight infections.

  • Empaveli can increase your risk of contracting serious meningococcal infections that can be life-threatening.
  • Meningococcal infections can quickly become life-threatening and even cause death if not treated promptly.
  • Empaveli can also increase the chance of contracting severe infections. People who take Empaveli could have a higher chance of contracting illnesses that are caused by Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae Type B. Infections that are serious can quickly become life-threatening and lead to death if they aren't identified and treated in time.
  • You should be vaccinated against this bacteria at least two weeks prior to your first dose if you have not received these vaccines previously.
  • If your doctor determines that urgent treatment with Empaveli is required, then you must get the necessary vaccinations as soon as possible.
  • If you're not immunised and the Empaveli treatment must be taken immediately, you should get two weeks of antibiotics along with your vaccinations.
  • If you've had a vaccination against the bacteria in the past, you may require additional vaccinations prior to beginning treatment. Your physician will decide whether you require additional vaccinations.
  • Vaccines can reduce the chance of contracting serious infections, but they do not eliminate all serious infections. Contact your doctor or seek medical emergency care immediately if you notice any of the following signs and symptoms of a serious illness:
    • the fever without or with shivers or chills
    • The rash and fever
    • breathlessness
    • extreme discomfort or pain.
    • nausea, nausea, or vomiting
    • high heart rate
    • A fever and headache
    • headaches with stiff necks or a stiff back
    • confusion
    • Muscles ache with flu-like symptoms.
    • Eyes sensitive to light
    • clammy skin

Your doctor will issue you a patient safety card to help you understand the risks of serious illnesses. Carry it with you at all times throughout treatment and for two months following the last dose. The risk of contracting serious infections could persist for a few weeks following your last dose. It is crucial to show your card in person to every health professional who is treating you. This will assist them in diagnosing and treating you swiftly.

Empaveli is only accessible through a programme known as Empaveli REMS. Empaveli REMS. Before you can use Empaveli, your doctor must:

  • Enrol in the Empaveli REMS programme.
  • Inform you about the possibility of serious infection caused by specific bacteria.
  • We will provide information on signs of serious infections.
  • They will provide you with a Patient Safety Card about your potential for serious infections like the one we discussed earlier.
  • ensure that you're sure that you have been vaccinated.

How to Take Empaveli?

Do not consume Empaveli if you:

  • You may be sensitive to pegcetacoplan or any other ingredient. Check out the conclusion in this medication guide for a full description of all the components.
  • Have not received vaccinations to protect yourself from Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type B, unless your doctor determines that immediate intervention with Empaveli is required. Check out the following important information:
  • Have grave Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B infections.
  • Check out the specific Instructions for Use with your prescription to learn more about how you can prepare and inject the dose of Empaveli.
  • Your doctor should be able to show you the proper way to make and use Empaveli prior to using it for the first time.
  • Take this medication exactly as your healthcare professional advises you to. Your healthcare professional will inform you of the dosage to use as well as how frequently. Make sure you do not take in more or less than what your doctor directs you to.
  • Empaveli is a treatment that involves infusions under the skin (subcutaneously) into your stomach (abdomen) or the back of your upper arms or hips with an injection pump.
  • Empaveli is given as two infusions per week. If you notice an increase in LDH or an enzyme that is present in blood samples, a physician might advise you to take the medication every three days.
  • If you're changing your treatment from eculizumab to empaveli, You should continue to take eculizumab for four weeks following your initial dose of Empaveli. After four weeks, you must discontinue treatment with eculizumab.
  • If you're changing your treatment from the drug eculizumab to Empaveli, you should begin the first dose of Empaveli at least 4 weeks after the last dose of eculizumab.
  • If you suffer from PNH and stop taking Empaveli, the healthcare professional must monitor you closely for at least 8 weeks following the discontinuation of Empaveli. Removing treatment can cause a reduction in red blood cells as a result of PNH.
    Problems or symptoms that may result from the breakdown of red blood cells are:

    • lower haemoglobin levels in your blood
    • Blood in your urine
    • breathlessness
    • difficulty with swallowing
    • tiredness
    • discomfort in the stomach (abdomen)
    • blood clots
    • erectile dysfunction (ED)

If you are unable to take a dose, you should take the missed dose as quickly as possible. Your next dose will be taken according to your regular schedule.

Before you Take this Drug

Before taking Empaveli, be sure to inform your physician about your medical conditions, especially those that:

  • Have an illness or are suffering from an infection.
  • Are pregnant, planning to be pregnant, or plan to be pregnant. Empaveli may harm your unborn baby. Women who could be pregnant should undergo an examination for pregnancy prior to starting treatment.
    • Females who can become pregnant should utilise an effective method for pregnancy control (contraception) during treatment and for the next 40 days following the dose that is taken.
  • Are breastfeeding or plan to be. It is unclear whether empaveli is absorbed into milk. Do not give birth to babies during treatment or for a period of 40 days following the last dose.

Talk to your doctor about every medicine you use, such as medications that are prescribed and available over the counter, such as vitamins and herbal supplements. Empaveli and other medications can interact with each other, leading to negative side effects.

Take note of the medicines you take and the vaccines you get. Keep a list to show your healthcare professional and pharmacist when you receive the latest medication.

Side effects of Empaveli

Empaveli can have severe side effects, including:

  • Check out important information.
  • Allergy reactions. Allergies can occur in the course of an Empaveli infusion. Stop your infusion and notify your doctor or seek immediate medical assistance when you notice any of these symptoms in your infusion.
    • chest pain
    • difficulty breathing or shortness of breath
    • swelling of your tongue, face, or throat
    • Feel faint or pass out.

The most commonly reported adverse effects for people suffering from PNH, which is treated by Empaveli, include reactions to injection sites and infections, diarrhoea and stomach pain (abdomen), respiratory tract infections, viral infections, and fatigue.
Talk to your healthcare provider about any adverse side effect that is bothering you or does not disappear. There are many possible negative side effects. For more details, consult your doctor or pharmacist. Contact your physician to get medical advice on adverse effects. You can report adverse reactions to the FDA at 1-800-FDA-1088.

Interaction with Other Drugs

Other medications may be incompatible with pegcetacoplan, such as medications that are prescribed and available over the counter, vitamins, and herbal products. Inform your physician about any other medicines you take.



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