Alhemo Side Effects

Generic name: concizumab

Note: This document provides detailed information about Alhemo Side Effects associated with concizumab. Some dosage forms listed on this page may not apply specifically to the brand name Alhemo.

Applies to concizumab: subcutaneous solution.

Important warnings This medicine can cause some serious health issues

Use only as directed.

Tell your doctor if you use other medicines or have other medical conditions or allergies.

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

Concizumab (the active ingredient contained in Alhemo) can cause unwanted blood clots, especially if you also use other medicines to help treat bleeding episodes or if you have certain other conditions. Call your doctor at once if you have:

• sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, confusion;

• problems with vision or balance, eye pain or swelling;

• severe chest pain, sudden cough or shortness of breath, coughing up blood;

• sudden stomach or back pain; or

• swelling, or warmth in one leg.

Common side effects may include:

• pain, bruising, swelling, or irritation where the medicine was injected; or

• hives.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to concizumab: subcutaneous solution.

General adverse events

The most common adverse reactions occurring in more than 5% of patients included injection site reactions, urticaria, arthralgia, upper respiratory tract infection, and increased coagulation biomarkers.^[Ref]

Cardiovascular

• Common (1% to 10%): Venous and arterial thromboembolic events

Dermatologic

• Common (1% to 10%): Urticaria/injection site urticaria
• Uncommon (0.1% to 1%): Pruritus

Hematologic

• Common (1% to 10%): Increased prothrombin fragment 1.2, increased fibrin D-dimer

Hypersensitivity

• Common (1% to 10%): Hypersensitivity reaction

Hypersensitivity reactions included erythema, rash, pruritus, abdominal pain, and anaphylaxis.

Immunologic

• Very common (10% or more): Neutralizing antidrug antibodies (up to 25.5%), antidrug antibodies (up to 25.4%)

Local

• Very common (10% or more): Injection site reactions (up to 23%)

Injection site reactions included injection site: rash, erythema, urticaria, bruising, hematoma, swelling, pruritus, hemorrhage, hypoesthesia, induration, and pain.

The most commonly occurring injection site reactions included injection site erythema (7.9%) and injection site bruising (3.5%).

Musculoskeletal

• Very common (10% or more): Arthralgia (up to 11%)

Nervous system

• Common (1% to 10%): Headache

Other

• Common (1% to 10%): Pyrexia
• Frequency not reported: Sudden death

Renal

• Common (1% to 10%): Renal infarct

Respiratory

• Common (1% to 10%): Upper respiratory tract infection
• Frequency not reported: COVID-19

Further information

Alhemo side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer