Applies to conestat alfa: intravenous solution reconstituted.

Serious side effects of Conestat alfa

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Very bad dizziness or passing out.
• Change in color of mouth to blue.
• A fast heartbeat.
• Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

Other side effects of Conestat alfa

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Diarrhea.
• Headache.
• Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to conestat alfa: intravenous powder for injection.

General

The most common adverse reactions were headache, nausea, and diarrhea.^[Ref]

Nervous system

Very common (10% or more): Headache (up to 10%)

Common (1% to 10%): Vertigo, procedural headache

Uncommon (0.1% to 1%): Paresthesia^[Ref]

Dermatologic

Common (1% to 10%): Angioedema, erythema marginatum, skin burning sensation

Uncommon (0.1% to 1%): Urticaria

Postmarketing reports: Rash^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea

Uncommon (0.1% to 1%): Abdominal discomfort, oral paresthesia

Postmarketing reports: Abdominal pain^[Ref]

Respiratory

Common (1% to 10%): Sneezing

Uncommon (0.1% to 1%): Throat irritation^[Ref]

Hematologic

Common (1% to 10%): Fibrin D-dimer increased^[Ref]

Immunologic

Common (1% to 10%): C-reactive protein increased^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain^[Ref]

Ocular

Common (1% to 10%): Lipoma

Other

Uncommon (0.1% to 1%): Swelling^[Ref]