Crovalimab is used to treat paroxysmal nocturnal hemoglobinuria (PNH) in adults and children at least 13 years of age and older weighing at least 88 lbs (40 kg).

Crovalimab is available only from a certified pharmacy under a special program.

Crovalimab may also be used for purposes not listed in this medication guide.

You should not be treated with crovalimab if you are allergic to it, or if you have a meningococcal infection (such as meningitis or sepsis).

You will need to receive a vaccine to protect against meningococcal infections at least 2 weeks before you start using crovalimab. Make sure people receiving crovalimab are vaccinated against pneumonia. Your child may also receive an influenza type B (Hib) vaccine.

If you need to start receiving this medicine before you are vaccinated, you may be given antibiotic medicine during the first 2 weeks of crovalimab treatment.

Tell your doctor if you have recently had any symptoms of infection (fever, chills, or flu-like symptoms).

It is not known if crovalimab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed while using crovalimab, and for at least 9 months after your last dose.

Use Crovalimab (Injectable) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Seek medical treatment or call your doctor if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, itching, fever, muscle, joint, or bone pain, headache, weakness, tiredness, or lack of energy, abdominal pain or upset stomach, kidney problems, or numbness or tingling in your hands and feet.

Call your doctor right away if you have signs of infection such as:

• muscle pain with flu-like symptoms;
• fever and a rash;
• stiffness in your neck or back;
• headache with nausea or vomiting;
• confusion; or
• your eyes may be more sensitive to light.

Call your doctor at once if you have symptoms of gonorrhea, such as:

• pain or burning when you urinate;
• pain or swelling of the genital or rectal area;
• unusual vaginal bleeding; or
• foul discharge from the penis or vagina.

If you stop using crovalimab, tell your doctor if you have any new or worsening symptoms, such as: tiredness, confusion, stomach pain, chest pain, trouble breathing or swallowing, trouble having an erection (in men), blood in your urine, a seizure, or loss of consciousness.

Common side effects may include:

• muscle, joint, or bone pain;
• kidney problems;
• numbness or tingling in your hands and feet;
• abdominal pain or upset stomach, nausea, vomiting;
• skin rash, fever, body aches, sweating, feeling weak or tired;
• headache, dizziness, chest tightness, back pain, trouble breathing, or swelling in your face; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.