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

Nplate is a prescription medicine 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.

Nplate is for use in adults and children who are at least 1 year old.

Nplate is also used to treat people including newborns who have been exposed to high levels of radiation (acute radiation syndrome). The effectiveness of Nplate for this use was only studied in animals, because it could not be studied in people.

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

Nplate may increase your risk of a blood clot or stroke. Call your doctor right away if you have signs of a blood clot, such as sudden numbness or weakness on one side of the body, chest pain, problems with speech or balance, warmth or swelling in an arm or leg.

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

Using Nplate 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 Nplate, 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 Nplate. Your blood will need to be tested weekly during this time.

Nplate is injected under the skin, usually once per week. A healthcare provider will give you this injection.

It may take up to 4 weeks of before Nplate is completely effective in preventing bleeding episodes. Keep receiving the medication as directed. Talk with your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment.

Using Nplate long-term can cause harmful effects on your bone marrow that may result in serious blood cell disorders. You will need frequent blood tests. Your treatment with this medicine may be delayed or permanently discontinued based on the results.

After you stop using Nplate, 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 Nplate. Your blood will need to be tested weekly during this time.

Usual Adult Dose for Idiopathic (Immune) Thrombocytopenic Purpura:

Initial dose: 1 mcg/kg subcutaneous injection once a week based on actual body weight; adjust the weekly dose by increments of 1 mcg/kg until the patients achieves a platelet count of 50 x 10(9)/L or greater

Maintenance dose: Use the lowest dose to achieve and maintain a platelet count of 50 x 10(9)/L or greater as needed to reduce bleeding risk.

Maximum dose: 10 mcg/kg/week

Duration of therapy: Discontinue this drug if platelets remain insufficient to avoid clinically important bleeding after 4 weeks at the maximum dose.

Comments: In clinical studies, most patients who responded to this drug achieved and maintained platelet counts of 50 x 10(9)/L or greater with a median dose of 2 mcg/kg.

Use: Treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy; use only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding.

Usual Pediatric Dose for Idiopathic (Immune) Thrombocytopenic Purpura:

1 Year or Older:
Initial dose: 1 mcg/kg subcutaneous injection once a week based on actual body weight; adjust the weekly dose by increments of 1 mcg/kg until the patients achieves a platelet count of 50 x 10(9)/L or greater

Maintenance dose: Use the lowest dose to achieve and maintain a platelet count of 50 x 10(9)/L or greater as needed to reduce bleeding risk.

Maximum dose: 10 mcg/kg/week

Comments:
-Dose adjustments are based on changes in platelet counts and changes in body weight. Reassessment of body weight is recommended every 12 weeks.
-In a pediatric placebo-controlled clinical study, the median dose was 5.5 mcg/kg.

Use: Treatment of thrombocytopenia in patients with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy; use only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding.

You should not use Nplate if you are allergic to romiplostim.

Using Nplate may increase your risk of developing blood cancers, especially if you have a myelodysplastic syndrome (bone marrow failure disorder, sometimes called "preleukemia"). Talk with your doctor if you have concerns about this risk.

To make sure Nplate is safe for you, tell your doctor if you have ever had:

• blood or bone marrow cancer such as leukemia, or myelodysplastic syndrome;

• bleeding problems or a blood clot;

• surgery to remove your spleen; or

• liver disease.

It is not known whether romiplostim will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of romiplostim on the baby.

You should not breastfeed while using Nplate.

Call your doctor for instructions if you miss an appointment for your Nplate injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

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

Call your doctor at once if you have:

• severe or ongoing diarrhea;

• purple or red spots under your skin;

• signs of an ear infection (more common in children) - fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child;

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems;

• signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• signs of a blood clot in your leg - swelling, warmth, or redness in an arm or leg.

Common Nplate side effects may include:

• bruising;

• headache;

• dizziness;

• joint pain, muscle weakness or tenderness;

• pain in your arms, legs, or shoulder;

• numbness or tingling in your hands or feet;

• trouble sleeping;

• stomach pain, indigestion, nausea, vomiting, diarrhea;

• cough, wheezing, chest tightness, trouble breathing;

• stuffy nose, sneezing, sinus pain; or

• pain in your mouth and throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with romiplostim, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.