Cablivi
Cablivi (caplacizumab or caplacizumab-yhdp) is the first medication available for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP) in adults. In order for it to work, it must be taken in combination with plasma exchange and immunosuppressants (medications that lower your immune system). After a starting dose that's given through your veins by a healthcare provider, Cablivi (caplacizumab) is injected under the skin daily. Treatment typically lasts a little over 1 to 2 months. Some common side effects include bloody nose, headache, and bleeding gums.
What is Cablivi (caplacizumab)?
What is Cablivi (caplacizumab) used for?
- Acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressants (medications that lower your immune system)
How Cablivi (caplacizumab) works
Cablivi (caplacizumab) treats aTTP by sticking to von Willebrand factor (vWF) in your blood. This prevents your platelets from clumping together to form clots and also keeps your platelet level in the rest of your body from dropping too low.
Drug facts
Side effects of Cablivi (caplacizumab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Nosebleeds (29%)
- Headache (21%)
- Bleeding gums (16%)
- Feeling tired (15%)
- Rash and hives (14%)
- Fever (13%)
- "Pins and needles" feeling (12%)
- Difficulty breathing (9%)
- Back pain (7%)
- Muscle pain (6%)
- Urinary tract infection (6%)
- Bleeding at injection or catheter site (6%)
Less Common Side Effects
- Bleeding in rectum or stomach
- Blood in urine
- Heavy menstrual bleeding
- Itching at injection site
Cablivi (caplacizumab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Severe bleeding: fast heart rate, dizziness, light-headedness, pale skin, blood in urine or stool, vomiting or couging up blood
The following Cablivi (caplacizumab) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Back pain
- Bleeding from the nose or gums that won't stop
- Fatigue
- Headache
- Muscle pain
Pros and cons of Cablivi (caplacizumab)
Pros
- Only needs to be taken for about 1 to 2 months after you finish your plasma exchange
- Works well for the treatment of aTTP
- Given only once per day
Cons
- Needs to be injected under the skin
- Needs to be given together with plasma exchange and immunosuppressants
- Brand name only, which can be expensive
Pharmacist tips for Cablivi (caplacizumab)
- Your first dose of Cablivi (caplacizumab) will be given to you by a healthcare provider in the hospital as an IV injection. Then, you or your caregiver can give you the rest of the Cablivi (caplacizumab) injections under the skin at home.
- Read the instructions on how to mix the medication and how to give yourself Cablivi (caplacizumab) injections. Make sure your provider or pharmacist teach you how to give yourself Cablivi (caplacizumab) so that you avoid accidentally hurting yourself or wasting the medication. Contact your provider or pharmacist if you have any questions on how to use this medication.
- Before using Cablivi (caplacizumab), take the medication out of the refrigerator. Hold the vial and syringe in your hand for 10 seconds to warm them up. Don't try to warm it up any other way, such as with a microwave, because doing so can damage your medication.
- Cablivi (caplacizumab) must be mixed before you inject it. Each carton comes with a vial of medication and a s__yringe with sterile water__ that must be added to the vial. Don't inject the contents of the vial without first mixing it with the sterile water.
- Use Cablivi (caplacizumab) immediately after mixing. However, if this isn't possible, you can store it for up to 4 hours in the refrigerator.
- After you inject Cablivi (caplacizumab), throw away the syringe and needle in a sharps container or something made of heavy-duty plastic, such as an empty milk carton or laundry detergent bottle, to lower the risk of needle-stick injuries. Don't throw away them away in your trash can. When your sharps container is almost full, close it tightly with the cap. For more information on how to throw away your sharps container safely and guidance for your specific state, visit the FDA's website.
- Store Cablivi (caplacizumab) in the refrigerator in the original carton to protect it from light. However, for convenience, you can store Cablivi (caplacizumab) at room temperature for up to 2 months. Once placed at room temperature, don't put it back in the refrigerator.
- Let your provider know in advance if you're scheduled for a surgery or procedure that might cause bleeding, including dental procedures. Your provider might ask you to stop taking Cablivi (caplacizumab) 7 days before you undergo any surgery or procedure, since Cablivi (caplacizumab) raises your risk for bleeding.
- Make sure to tell your provider about all the medications you're taking before starting Cablivi (caplacizumab), especially if you're taking an antiplatelet, such as aspirin, or an anticoagulant, such as warfarin (Coumadin), because these raise your risk for bleeding. Don't start any new medications while taking Cablivi (caplacizumab) without talking to your provider or pharmacist first.
Common questions about Cablivi (caplacizumab)
Normally, when you get an injury and start to bleed, your body releases a protein called von Willebrand factor (vWF). This protein sticks to platelets in your blood and causes them to clump up and form clots to stop your bleeding. After your injury is healed, your body releases another protein called ADAMTS13. This protein chops up vWF so that platelets don't clump together to form clots anymore. In people with acquired thrombotic thrombocytopenic purpura (aTTP), ADAMTS13 doesn't work properly. As a result, you have a lot of vWF in your body, which causes your platelets to form clots even if you don't need them to. When a lot of platelets gather together and clot in certain areas of your body, it means the platelet level in the rest of your body is low and this can lead to bleeds. So people with aTTP are at higher risk for both blood clot-related complications and bleeds.
Only your first dose of Cablivi (caplacizumab) is given IV by a healthcare provider. After that, Cablivi (caplacizumab) can be given by a provider, yourself, or your caregiver and only as an injection under the skin in your stomach. To lower the risk of bruising and irritation, rotate between different injection sites on your stomach so that the same site isn't used repeatedly. Make sure to inject at least 2 inches away from your belly button.
Treatment with Cablivi (caplacizumab) can last a little over 1 to 2 months. It starts when you begin your plasma exchange and you'll get daily Cablivi (caplacizumab) injections after each plasma exchange. After your final plasma exchange session, you'll continue to inject Cablivi (caplacizumab) daily for about a month. Depending on how you respond to the medication, your provider might extend your Cablivi (caplacizumab) treatment by up to another month. If you get 2 episodes of aTTP while taking Cablivi (caplacizumab), you'll have to stop taking the medication. Talk with your provider if you're not sure how long you need to take Cablivi (caplacizumab).
If you miss a dose of Cablivi (caplacizumab) during the period when you're also receiving plasma exchange, take it as soon as you remember. If you miss a dose of Cablivi (caplacizumab) after you're no longer receiving plasma exchange, take the dose as long as it's within 12 hours of when you're supposed to take it. If it has been longer than 12 hours, skip the dose and continue the next dose at the usual time the following day.
Cablivi (caplacizumab) hasn't been studied in pregnancy, so it's not known whether this medication is safe or works well in pregnant females. It's possible that this medication raises the risk of serious bleeds for both mother and child. If you're pregnant or thinking of becoming pregnant, talk with your provider about the risks and benefits of using Cablivi (caplacizumab) during pregnancy.
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Risks and warnings for Cablivi (caplacizumab)
Cablivi (caplacizumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
High risk of bleeding
- Risk factors: Bleeding problems | Taking medications together with Cablivi (caplacizumab) that raise your bleeding risk
Cablivi (caplacizumab) can put you at risk for serious bleeds, especially if you have bleeding problems or if you're taking medications that raise your risk for bleeding (e.g., antiplatelets and anticoagulants). Make sure to tell your provider about all the medications you're taking before starting Cablivi (caplacizumab). Don't start any new medications while taking Cablivi (caplacizumab) without talking to your provider first.
Let your provider know ahead of time if you're planning to receive any surgery, procedure, or dental work. Your provider might have you stop Cablivi (caplacizumab) about 1 week before these procedures to lower your risk for bleeds. If you're getting an emergency surgery, let your provider know you're taking Cablivi (caplacizumab) because you might need to receive additional medications ahead of time to prevent bleeds. If you have any signs of severe bleeding (e.g., fast heart rate, dizziness, light-headedness, pale skin, blood in urine or stool, vomiting or couging up blood) or having difficulty stopping a bleed, get medical help right away.
Cablivi (caplacizumab) dosage
Typical dosage for Cablivi (caplacizumab)
You typically start treatment of Cablivi (caplacizumab) when you start your plasma exchange. Your first dose of Cablivi (caplacizumab) is injected into the veins by a healthcare provider. After this, your doses of Cablivi (caplacizumab) can be injected under the skin by a provider, yourself, or your caregiver.
- 1st day of treatment: The typical dose is 11 mg of Cablivi (caplacizumab) injected into the veins (IV) at least 15 minutes before plasma exchange by a healthcare provider. Another 11 mg of Cablivi (caplacizumab) is injected under the skin after your plasma exchange.
- Treatment during daily plasma exchange: The typical dose is 11 mg of Cablivi (caplacizumab) injected under the skin daily after plasma exchange.
- Treatment after the last day of plasma exchange: The typical dose is 11 mg injected under the skin daily for about 1 month. Your provider might have you continue taking Cablivi (caplacizumab) for up to about another month, depending on how you're responding to the medication.