Nplate

What is Nplate used for?

Nplate is a prescription medicine that is used to raise platelet counts.

It is used to treat immune thrombocytopenia (ITP).

Description

Romiplostim is a thrombopoietin receptor agonist (TPO-RA). Romiplostim, a member of the TPO mimetic class, is an Fc-peptide fusion protein (peptibody). The peptibody molecule contains two identical single-chain subunits, each consisting of human immunoglobulin IgG1 Fc domain, covalently linked at the C-terminus to a peptide containing two thrombopoietin receptor-binding domains. Romiplostim has no amino acid sequence homology to endogenous TPO. Romiplostim is produced by recombinant DNA technology in Escherichia coli (E. coli).

Nplate (romiplostim) for injection is supplied as a sterile, preservative-free, lyophilized, solid white powder for subcutaneous use. Nplate is supplied as either 125 mcg per vial, 250 mcg per vial or 500 mcg per vial of romiplostim and requires reconstitution with Sterile Water for Injection to obtain a concentration of 500 mcg/mL.

Each single-dose 125 mcg vial of Nplate contains the following: 125 mcg of romiplostim, L-histidine (0.7 mg), mannitol (18 mg), polysorbate 20 (0.02 mg), sucrose (9 mg), and sufficient HCl to adjust the pH to a target of 5. Reconstitution with 0.44 mL of Sterile Water for Injection provides a resulting concentration of 125 mcg/0.25 mL.

Each single-dose 250 mcg vial of Nplate contains the following: 250 mcg romiplostim, L-histidine (1.2 mg), mannitol (30 mg), polysorbate 20 (0.03 mg), sucrose (15 mg), and sufficient HCl to adjust the pH to a target of 5. Reconstitution with 0.72 mL of Sterile Water for Injection provides a resulting concentration of 250 mcg/0.5 mL.

Each single-dose 500 mcg vial of Nplate contains the following: 500 mcg romiplostim, L-histidine (1.9 mg), mannitol (50 mg), polysorbate 20 (0.05 mg), sucrose (25 mg), and sufficient HCl to adjust the pH to a target of 5. Reconstitution with 1.2 mL of Sterile Water for Injection provides a resulting concentration of 500 mcg/mL.

Mechanism of Action

Nplate increases platelet production through binding and activation of the TPO receptor, a mechanism analogous to endogenous TPO.

Before taking Nplate, tell your doctor:

• If you are allergic to Nplate; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are breast-feeding. Do not breast-feed while you take Nplate.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Nplate with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Nplate?

For all patients taking Nplate:

• Tell all of your health care providers that you take Nplate. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Use care to prevent injury and avoid falls or crashes.
• Low platelet levels and a raised chance of bleeding may happen when Nplate is stopped. If Nplate is stopped, have your blood work checked for at least 2 weeks after stopping it. Talk with your doctor.
• This medicine may raise the chance of blood clots. This includes some forms of blood clots that spread to the lungs or that cause strokes or heart attacks. Talk with the doctor.
• This medicine is not for use in people with a certain bone marrow problem called myelodysplastic syndrome (MDS). If you have MDS and you take Nplate, MDS may get worse and turn into a type of blood cancer called acute myelogenous leukemia (AML). If MDS turns into AML, you could die sooner from AML. If you have MDS, talk with your doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Nplate, call your doctor right away.

Children:

• If your child’s weight changes, talk with the doctor. The dose of Nplate may need to be changed.

How is Nplate best taken?

Use Nplate as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Nplate that I need to call my doctor about immediately?

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.
• Any unexplained bruising or bleeding.
• Swelling in the arms or legs.
• A burning, numbness, or tingling feeling that is not normal.
• Ear pain.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• 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.

What are some other side effects of Nplate?

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:

For all patients taking Nplate:

• Signs of a common cold.
• Mouth or throat pain or irritation.
• Stomach pain or diarrhea.
• Cough.

Adults:

• Dizziness or headache.
• Joint pain.
• Heartburn.
• Muscle pain or weakness.
• Shoulder pain.
• Pain in arms or legs.
• Trouble sleeping.
• Upset stomach or throwing up.

Children:

• Fever.

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.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Nplate?

• If you need to store Nplate at home, talk with your doctor, nurse, or pharmacist about how to store it.