Nplate

DRUG DESCRIPTION

Romiplostim, a member of the TPO mimetic class, is an Fc-peptide fusion protein (peptibody) that activates intracellular transcriptional pathways leading to increased platelet production via the TPO receptor (also known as cMpl). 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 is supplied as a sterile, preservative-free, lyophilized, solid white powder for subcutaneous injection. Two vial presentations are available, which contain a sufficient amount of active ingredient to provide either 250 mcg or 500 mcg of deliverable romiplostim, respectively. Each single-use 250 mcg vial of Nplate contains the following: 375 mcg romiplostim, 30 mg mannitol, 15 mg sucrose, 1.2 mg L-histidine, 0.03 mg polysorbate 20, and sufficient HCl to adjust the pH to a target of 5.0. Each single-use 500 mcg vial of Nplate contains the following: 625 mcg romiplostim, 50 mg mannitol, 25 mg sucrose, 1.9 mg L-histidine, 0.05 mg polysorbate 20, and sufficient HCl to adjust the pH to a target of 5.0 [see DOSAGE AND ADMINISTRATION].

What are the possible side effects of romiplostim (Nplate)?

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

Less serious side effects may include:

  • headache;
  • dizziness;
  • joint or muscle pain;
  • pain in your arms, legs, or shoulder;
  • numbness or tingly feeling;
  • sleep problems (insomnia); or
  • stomach pain or upset.

This is not a complete list of side effects and others may occur. Tell your doctor...

Read All Potential Side Effects and See Pictures of Nplate

What are the precautions when taking romiplostim (Nplate)?

Before using romiplostim, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots, other blood disorders (such as blood cancer, myelodysplastic syndrome).

Before having surgery, tell your doctor or dentist that you are using this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Nplate


Nplate Consumer (continued)

SIDE EFFECTS: Headache, joint/muscle pain, dizziness, heartburn, abdominal pain, tingling/numbness in hands/feet, and trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may rarely cause serious problems from blood clots to the heart, brain or lung (such as pulmonary embolism, stroke, heart attack), especially if your platelet counts are too high. Keep all medical/lab test appointments. Seek immediate medical attention if you experience: sudden shortness of breath, chest/jaw/left arm pain, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, slurred speech, weakness on one side of the body, vision problems/changes.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using romiplostim, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots, other blood disorders (such as blood cancer, myelodysplastic syndrome).

Before having surgery, tell your doctor or dentist that you are using this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Nplate Patient Information Including Side Effects

Brand Names: Nplate

Generic Name: romiplostim (Pronunciation: ROM i PLOS tim)

  • What is romiplostim (Nplate)?
  • What are the possible side effects of romiplostim (Nplate)?
  • What is the most important information I should know about romiplostim (Nplate)?
  • What should I discuss with my health care provider before receiving romiplostim (Nplate)?
  • How is romiplostim given (Nplate)?
  • What happens if I miss a dose (Nplate)?
  • What happens if I overdose (Nplate)?
  • What should I avoid while receiving romiplostim (Nplate)?
  • What other drugs will affect romiplostim (Nplate)?
  • Where can I get more information?

What is romiplostim (Nplate)?

Romiplostim is a man-made form of a protein that increases production of platelets (blood-clotting cells) in your body.

Romiplostim is used to prevent bleeding episodes in people with chronic immune thrombocytopenic purpura (ITP), a bleeding condition caused by a lack of platelets in the blood.

Romiplostim is usually given after other medications have been tried without successful treatment of symptoms.

Romiplostim is not a cure for ITP and it will not make your platelet counts normal if you have this condition.

Romiplostim may also be used for other purposes not listed in this medication guide.

What are the possible side effects of romiplostim (Nplate)?

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

Less serious side effects may include:

  • headache;
  • dizziness;
  • joint or muscle pain;
  • pain in your arms, legs, or shoulder;
  • numbness or tingly feeling;
  • sleep problems (insomnia); or
  • stomach pain or upset.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about romiplostim (Nplate)?

Romiplostim is available only under a special program called Nplate NEXUS. You must be enrolled in this program and sign all required agreements in order to receive the medication. Read all program brochures and agreements carefully.

Romiplostim is not a cure for ITP and it will not make your platelet counts normal if you have this condition.

Before you use romiplostim, tell your doctor if you have kidney or liver disease.

Using romiplostim long-term can cause harmful effects on your bone marrow that may result in serious blood cell disorders. To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Do not miss any scheduled visits to your doctor.

It may take up to 4 weeks of using this medicine before it is completely effective in preventing bleeding episodes. Talk with your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment.

After you stop using romiplostim, your risk of bleeding may be even higher than it was before you started treatment. Be extra careful to avoid cuts or injury for at least 2 weeks after you stop using romiplostim. Your blood will need to be tested weekly during this time.

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