Why is this medication prescribed?

Cablivi (caplacizumab) is prescribed for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP) in adults. aTTP is a rare blood disorder characterized by the formation of blood clots in small blood vessels throughout the body. Cablivi works by inhibiting the interaction between von Willebrand factor (vWF) and platelets, thereby preventing the formation of blood clots.

How should this medicine be used?

How Cablivi should be used:

• Administration: Cablivi is administered as an intravenous infusion by a healthcare professional.
• Dosage: The initial dose is typically 11 mg given as an intravenous bolus injection, followed by a maintenance dose of 11 mg administered via intravenous infusion once daily. The duration of treatment is generally until 30 days after the last daily plasma exchange.
• Monitoring: Patients receiving Cablivi should be monitored closely for any signs of bleeding. If significant bleeding occurs, Cablivi administration should be discontinued.
• Plasma Exchange: Cablivi treatment should be initiated as soon as possible alongside plasma exchange and corticosteroids, which are standard treatments for aTTP.
• Follow-up: After discontinuation of Cablivi, patients should be monitored for recurrence of symptoms of aTTP.

It’s important for patients to follow their healthcare provider’s instructions carefully regarding the dosage and administration of Cablivi to ensure effective treatment and minimize potential risks.

Other uses for this medicine

Cablivi (caplacizumab) is primarily used for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP) in adults, as mentioned earlier. Currently, there are no other approved uses for Cablivi beyond this specific indication.

What special precautions should I follow?

Special precautions for Cablivi:

• Bleeding Risk: Cablivi increases the risk of bleeding, so it should be used with caution in patients who have an increased risk of bleeding or who are taking medications that increase bleeding risk (e.g., anticoagulants, antiplatelet agents).
• Monitoring: Close monitoring for signs of bleeding is essential during treatment with Cablivi. This includes monitoring for any unusual bleeding or bruising.
• Discontinuation for Bleeding: Cablivi should be discontinued if severe bleeding occurs. Treatment should be restarted only after the bleeding has resolved.
• Immunogenicity: Like with all therapeutic proteins, there is potential for immunogenicity (formation of antibodies against the drug). Patients should be monitored for signs of immune reactions.
• Pregnancy and Breastfeeding: The safety of Cablivi during pregnancy and breastfeeding has not been established. Therefore, it should only be used in pregnant or breastfeeding women if clearly needed and the potential benefits outweigh the risks.
• Hypersensitivity Reactions: Patients should be monitored for signs of hypersensitivity reactions (e.g., rash, itching, swelling) during Cablivi administration. In case of a severe reaction, treatment should be discontinued and appropriate medical therapy initiated.
• Liver Function: Cablivi may affect liver function, so liver function tests should be performed periodically during treatment.
• Pediatric Use: The safety and effectiveness of Cablivi in pediatric patients have not been established.
• Drug Interactions: Cablivi has the potential to interact with other medications. Healthcare providers should be informed of all medications, including over-the-counter drugs and herbal supplements, that patients are taking.

Patients should discuss any concerns or questions about Cablivi with their healthcare provider to ensure safe and effective treatment.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Cablivi. However, maintaining a balanced diet and staying hydrated are generally recommended for overall health and well-being during treatment.

What should I do if I forget a dose?

If you miss a dose of Cablivi, contact your healthcare provider or clinic as soon as possible to discuss the missed dose and receive further guidance. Depending on the timing and schedule of your treatment, they will advise whether the missed dose should be administered or if any adjustments are necessary. It’s important not to double the dose to make up for a missed one unless instructed to do so by your healthcare provider.

What side effects can this medication cause?

Cablivi (caplacizumab) can cause several potential side effects. The most common side effects reported in clinical trials include:

• Bleeding: This is the most significant side effect of Cablivi. It can cause bleeding events such as nosebleeds, bleeding gums, bruising, and gastrointestinal bleeding.
• Headache: Headaches are a common side effect reported by patients receiving Cablivi.
• Hypertension (High Blood Pressure): Elevated blood pressure can occur during treatment with Cablivi.
• Infusion-related reactions: These may include symptoms such as fever, chills, itching, rash, and difficulty breathing.
• Nausea: Some patients may experience nausea as a side effect of Cablivi.
• Vomiting: Vomiting can also occur in some individuals receiving Cablivi.
• Fever: Fever has been reported as a side effect in clinical trials.
• Back pain: This can occasionally occur as a side effect of Cablivi.
• Abdominal pain: Some patients may experience abdominal pain during treatment.
• Fatigue: Feeling tired or fatigued is another potential side effect of Cablivi.

It’s important to note that while these are some of the common side effects observed with Cablivi, not all patients will experience them. Additionally, serious allergic reactions and severe bleeding can occur, although these are less common.

If you experience any side effects while receiving Cablivi, it’s important to notify your healthcare provider promptly. They can provide guidance on managing side effects and determine if any adjustments to your treatment are necessary.

What should I know about storage and disposal of this medication?

Storage of Cablivi:

• Refrigeration: Cablivi should be stored in the refrigerator between 2°C to 8°C (36°F to 46°F) in its original carton to protect it from light.
• Do not freeze: Do not freeze Cablivi. Freezing may damage the medication.
• Keep out of reach: Store Cablivi out of the reach of children and pets.
• Handling: Cablivi should be handled and administered by healthcare professionals trained in the administration of intravenous medications.

Disposal of Cablivi:

• Unused medication: Unused Cablivi should be disposed of properly according to local regulations or guidelines.
• Consultation: Consult your healthcare provider or pharmacist on how to properly dispose of any unused Cablivi.

In case of emergency/overdose

• Seek immediate medical attention: If you suspect an overdose of Cablivi or experience severe adverse effects, seek emergency medical attention or contact your healthcare provider immediately.
• Symptoms: Symptoms of overdose with Cablivi are not well-documented, but severe bleeding or allergic reactions may require urgent medical intervention.

What other information should I know?

• Monitoring: Regular monitoring for signs of bleeding, hypersensitivity reactions, and other adverse effects is essential during treatment with Cablivi.
• Follow-up: Attend all scheduled appointments with your healthcare provider for monitoring and evaluation of your response to Cablivi therapy.
• Patient Information: Ensure you have been provided with and understand all patient information and instructions for Cablivi, including its benefits, risks, and proper use.
• Interactions: Inform your healthcare provider about all medications you are taking, including prescription drugs, over-the-counter medications, vitamins, and herbal supplements, to avoid potential interactions.
• Pregnancy/Breastfeeding: Discuss with your healthcare provider the potential risks and benefits of using Cablivi if you are pregnant, planning to become pregnant, or breastfeeding.
• Storage: Always store Cablivi as directed and avoid using it if it has been stored improperly or if it is beyond its expiration date.

Following these guidelines will help ensure safe and effective use of Cablivi for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP). Always consult your healthcare provider if you have any questions or concerns about Cablivi or its use.