Romiplostim

What is Romiplostim?

• Romiplostim (Nplate) is a thrombopoietin receptor agonist used to treat thrombocytopenia (low platelet levels) in patients with immune thrombocytopenic purpura (ITP) that did not get better with other treatment.

Nplate (Romiplostim) 250mkg

What are the uses of this medicine?

Romiplostim (Nplate) is a prescription medicine used to treat low blood platelet counts (thrombocytopenia) in:

• adults with immune thrombocytopenia (ITP) when certain medicines or surgery to remove your spleen have not worked well enough.
• children 1 year of age and older with ITP for at least 6 months when certain medicines or surgery to remove your spleen have not worked well enough.

• Nplate is a prescription medicine 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.

Limitations of Use:

• Nplate is not for use in people with a precancerous condition called myelodysplastic syndrome (MDS), or low platelet count caused by any condition other than ITP.
• Nplate is only used if your low platelet count and medical condition increase your risk of bleeding.
• Nplate is used to try to keep your platelet count about 50,000 per microliter in order to lower the risk for bleeding. Nplate is not used to make your platelet count normal.
• It is not known if Nplate is safe and effective in children under the age of 1.

How does this medicine work?

• ITP is a condition in which platelets are destroyed by the immune system.
• Nplate binds to the thrombopoietin receptor, which causes the bone marrow to make more platelets.
• It is a type of thrombopoietin receptor agonist.
• Also called AMG 531.

Who Should Not Use this medicine ?

Limitations of Use:

• Nplate is not for use in people with a precancerous condition called myelodysplastic syndrome (MDS), or low platelet count caused by any condition other than ITP.
• Nplate is only used if your low platelet count and medical condition increase your risk of bleeding.
• Nplate is used to try to keep your platelet count about 50,000 per microliter in order to lower the risk for bleeding.
• Nplate is not used to make your platelet count normal.
• It is not known if Nplate is safe and effective in children under the age of 1.

What drug interactions can this medicine cause?

• Nplate may be used with other medical ITP therapies, such as corticosteroids, danazol, azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin.

Is this medicine FDA approved?

• On August 22, 2008, the FDA approved romiplostim as a long-term treatment for chronic ITP in adults who have not responded to other treatments, such as corticosteroids, intravenous immunoglobulin, Rho(D) immune globulin or splenectomy.

How should this medicine be used?

Recommended dosage: Patients with Immune Thrombocytopenia (ITP): Recommended Initial Dose:

• 1 mcg/kg once weekly as a subcutaneous injection.
• Adjust dose based on platelet response.

Patients with Hematopoietic Syndrome of Acute Radiation Syndrome:

• Recommended Dose: 10 mcg/kg administered once as a subcutaneous injection.
• Administer the dose as soon as possible after suspected or confirmed exposure to myelosuppressive doses of radiation.

Administration:

• Nplate for ITP is given by your healthcare provider as an injection under the skin (subcutaneous) one time each week.
• Nplate is given by your healthcare provider as an injection under the skin once for exposure to high levels of radiation.
• During treatment for ITP, your healthcare provider will closely monitor your Nplate dose and platelet counts.
• Your healthcare provider will check your platelet count every week and change your dose of Nplate as needed. This will continue until your healthcare provider decides that your dose of Nplate can stay the same. After that, you will need to get blood tests every month. When you stop receiving Nplate, you will need blood tests for at least 2 weeks to check if your platelet count drops too low.
• Tell your healthcare provider about any bruising or bleeding that occurs during treatment with Nplate.
• If you miss a scheduled dose of Nplate, call your healthcare provider to schedule your next dose as soon as possible.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 125 mcg, 250 mcg or 500 mcg of romiplostim as a lyophilized powder in single-dose vials.

This medicine is available in fallowing brand namesː

• Nplate

What side effects can this medication cause?

The most common side effects of Nplate in adults include:

• headache
• tingling or numbness in hands and feet
• joint pain
• bronchitis
• dizziness
• inflammation of the sinuses (sinusitis)
• trouble sleeping
• vomiting
• muscle tenderness or weakness
• pain in the arms and legs
• stomach (abdomen) pain
• shoulder pain
• indigestion
• diarrhea
• upper respiratory tract infection
• cough
• nausea
• pain in mouth and throat (oropharyngeal pain)

The most common side effects of Nplate in children 1 year of age and older include:

• bruising
• upper respiratory tract infection
• pain in mouth and throat (oropharyngeal pain)

Nplate can cause serious side effects, including:

• Worsening of a precancerous blood condition to a blood cancer (leukemia)
• Higher risk for blood clots

What special precautions should I follow?

• In some patients with MDS, Nplate increases blast cell counts and increases the risk of progression to acute myelogenous leukemia.
• Thrombotic/thromboembolic complications may result from increases in platelet counts with Nplate use. Portal vein thrombosis has been reported in patients with chronic liver disease receiving Nplate.
• If severe thrombocytopenia develops during Nplate treatment, assess patients for the formation of neutralizing antibodies.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications.

Management of overdosage:

• In this case, discontinue Nplate and monitor platelet counts.
• Reinitiate treatment with Nplate in accordance with dosing and administration recommendations.

Can this medicine be used in pregnancy?

• Nplate may cause fetal harm when administered to a pregnant woman.
• Available data with Nplate use in pregnant women are insufficient to draw conclusions about any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• Safety and effectiveness have been established in pediatric patients age 1 year and older with ITP for at least 6 months evaluated.
• The safety and efficacy of Nplate in pediatric patients younger than 1 year with ITP have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: romiplostim
• Inactive ingredients: L-histidine, mannitol, polysorbate 20, sucrose, and hydrochloric acid

Who manufactures and distributes this medicine?

Manufactured by: Amgen Inc., One Amgen Center Drive, Thousand Oaks, California

What should I know about storage and disposal of this medication?

• Store Nplate vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
• Do not freeze.
• If needed, unopened Nplate vials may be stored in the original carton at room temperature up to a maximum of 25°C (77°F) for a single period of up to 30 days.
• The new expiration date must be written in the space provided on the carton.
• Once stored at room temperature, do not place back in the refrigerator.
• If not used within the 30 days, discard Nplate.

• Dailymed label info on Romiplostim
• FDA Romiplostim

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