Pronunciation:

kroe-VAL-i-mab - akkz

Brand Names:

• PiaSky

Dosage Forms:

• Solution

Warnings:

Warning: Serious Meningococcal InfectionsCrovalimab-akkz, a complement inhibitor, increases the risk of serious and life-threatening infections caused by Neisseria meningitidis. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update meningococcal bacteria (for serogroups A, C, W, Y, and B) vaccination at least 2 weeks prior to the first dose of crovalimab-akkz, unless the risks of delaying crovalimab-akkz outweigh the risks of developing a serious infection. Comply with the most current advisory committee on immunization practices (ACIP) recommendations for meningococcal vaccination in patients receiving a complement inhibitor. Patients receiving crovalimab-akkz are at increased risk for invasive disease caused by N. meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected. Because of the risk of serious meningococcal infections, Crovalimab-akkz is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the PIASKY REMS .

Classifications:

Therapeutic—

Blood Modifier Agent

Pharmacologic—

Crovalimab

Uses of This Medicine:

Crovalimab-akkz injection is used to treat a type of blood disease called paroxysmal nocturnal hemoglobinuria (PNH). This medicine helps reduce red blood cell destruction or breakdown (hemolysis) in patients with PNH.

This medicine is available only under a restricted distribution program called Piasky™ REMS (Risk Evaluation and Mitigation Strategy) Program.

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of crovalimab-akkz injection in children younger than 13 years of age weighing less than 40 kilograms (kg). Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of crovalimab-akkz injection in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require caution in patients receiving this medicine.

Breast-feeding—

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.

Other medicines—

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—Use with caution. May increase risk of serious infections.

• Meningococcal infection, serious and unresolved—Should not be used in patients with this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. The first loading dose is given through an IV catheter that is placed into one of your veins. It must be injected slowly, so your IV may need to stay in place for at least 60 to 90 minutes on Day 1. Another loading dose will be given as a shot under your skin, usually in the stomach, on Days 2, 8, 15, and 22. The maintenance doses will begin on Day 29 and be given every 4 weeks as a shot under your skin.

It is very important that you understand the requirements of the Piasky™ REMS program, and become familiar with the Piasky™ Medication Guide. 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.

If you are changing treatment from Soliris® or Ultomiris® to Piasky™, you should start receiving Piasky™ as soon as possible. Your doctor will monitor you for 30 days after you switch medicines.

Missed dose—

Call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine can increase your risk for serious infections, including meningococcal infection, gonorrhea, pneumonia, and flu-like infection. You will need to be vaccinated against meningococcal infection at least 2 weeks before you start treatment with this medicine. You may also be given antibiotic medicine to prevent infections if you are to use this medicine right away. Avoid people who are sick or have infections. Tell your doctor right away if you develop headaches, nausea, vomiting, fever, a stiff neck or back, a rash, confusion, muscle aches, or if your eyes have become sensitive to light.

You will be given a patient safety card that lists the symptoms of infection and what to do if you have them. Carry the card with you at all times during treatment and for 11 months after treatment. Show the card to any doctor who treats you.

When this medicine is stopped, you may develop hemolysis (red blood cell breakdown). Your doctor will need to monitor you closely for at least 20 weeks after you stop using this medicine. Be sure to keep all appointments.

This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have difficulty breathing or swallowing, a fast heartbeat, itching, rash, or redness, or swelling of the face, throat, or tongue.

This medicine may cause infusion-related or injection-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have 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, fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

Side Effects of This Medicine:

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 or nurse immediately if any of the following side effects occur:

More common

Back pain

bloating or swelling of the face, arms, hands, lower legs, or feet

chest tightness

chills

cough

diarrhea

difficulty swallowing

ear congestion

fast heartbeat

fever

frequent or painful urination

flushing

headache

joint pain, stiffness, or swelling

loss of voice

lower back or side pain

muscle aches

nausea or vomiting

new loss of taste or smell

rapid weight gain

skin itching, rash, or redness

sneezing

sore throat

stomach pain

stuffy or runny nose

swelling of the face, throat, or tongue

swelling of the feet or lower legs

tingling of the hands or feet

trouble breathing

unusual tiredness or weakness

unusual weight gain or loss

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

Difficulty in moving

joint pain

muscle pain or stiffness

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.