Adakveo

Adakveo is a targeted biologic therapy used to reduce the frequency of pain crises in people with sickle cell disease.

Adakveo works by making blood vessels and certain blood cells less sticky by attaching to P-selectin, a sticky factor that plays a key role in blockages, also known as vaso-occlusion. By attaching to P-selectin, Adakveo blocks connections between certain cells such as red blood cells, white blood cells, and platelets.

Adakveo comes in an injectable form to be given directly into a vein (IV) by a healthcare provider, once monthly.

Common side effects include nausea, joint pain, back pain and fever.

Adakveo is a prescription medication used in people 16 years and older who have sickle cell disease to help reduce how often certain episodes (crises) happen. It is not known if Adakveo is safe and effective in children under 16 years of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Adakveo may cause serious side effects. See "Adakveo Precautions" section.

Common side effects include:

• nausea
• joint pain
• back pain
• fever

This is not a complete list of Adakveo side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your health care provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 

ADAKVEO may interfere with a blood test. Adakveo interferes with automated platelet counts (platelet clumping) in particular when blood samples are collected in tubes containing EDTA, which may lead to unevaluable or falsely decreased platelet counts.

Tell your health care provider that you are receiving Adakveo before having any blood tests. Adakveo may interfere with a laboratory test to measure your platelet counts.

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Adakveo may cause serious side effects, including infusion reactions. 

Infusion reactions. Infusion reactions may happen within 24 hours of receiving an infusion of Adakveo. Tell your health care provider right away if you get any of the following signs and symptoms of an infusion reaction:

• fever
• chills or shivering
• nausea
• vomiting
• tiredness
• dizziness
• sweating
• hives
• itching
• shortness of breath or wheezing

Your doctor or health care provider may monitor you for signs and symptoms of infusion reactions.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Adakveo there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving Adakveo, tell your health care provider about all of your medical conditions, including if you 

• are pregnant or plan to become pregnant. It is not known if Adakveo may harm your unborn baby
• are breastfeeding or plan to breastfeed. It is not known if Adakveo passes into your breast milk. You and your health care provider should decide the best way to feed your baby during treatment with Adakveo

Tell your health care provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans with Adakveo. In animal studies, pregnant animals were given this medication and there were no effects on infant growth and development through 6-months postpartum that were attributable to Adakveo, however, there was an increase in fetal loss (abortions or still births).

Because Adakveo has the potential to cause fetal harm when administered to a pregnant woman talk to your healthcare provider about the use of this medication during pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Adakveo crosses into human milk. Because many medications can cross into human milk and because the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Adakveo.

• Your healthcare provider will give you Adakveo as an infusion into your vein through an intravenous (IV) line over 30 minutes.
• You will receive your first infusion, and then a second infusion 2 weeks later. After that, you will receive an infusion every 4 weeks.
• Your healthcare provider may also prescribe other treatments for you to take during treatment with Adakveo.
• Do not stop receiving Adakveo unless your healthcare provider tells you to.
• If you miss an appointment for infusion, call your healthcare provider as soon as possible to reschedule.

The recommended dose is 5 mg/kg by intravenous infusion over a period of 30 minutes at Week 0, Week 2, and every 4 weeks thereafter.

Adakveo is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.