NPLATE- romiplostim injection, powder, lyophilized, for solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

ROMIPLOSTIM (UNII: GN5XU2DXKV) (ROMIPLOSTIM - UNII:GN5XU2DXKV)

थमां उपलब्ध:

Amgen Inc

INN (इंटरनेशनल नाम):

ROMIPLOSTIM

रचना:

ROMIPLOSTIM 500 ug in 1 mL

प्रशासन का मार्ग:

SUBCUTANEOUS

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Nplate is indicated for the treatment of thrombocytopenia in: - Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. - Pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Nplate is indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation [see Clinical Studies (14.3)] . Limitations of Use: - Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP [see Warnings and Precautions ( 5.1 )] .   - Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. - Nplate should not be used in an attempt to normalize platelet counts [see Warnings and Precautions ( 5.2 )]

उत्पाद समीक्षा:

Nplate (romiplostim) for injection is supplied as a sterile, preservative-free, solid white lyophilized powder in single-dose vials of 125 mcg (NDC-55513-223-01), 250 mcg (NDC 55513-221-01) and 500 mcg (NDC 55513-222-01) of romiplostim. 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.

प्राधिकरण का दर्जा:

Biologic Licensing Application

सूचना पत्रक

NPLATE- romiplostim injection, powder, lyophilized, for solution
Amgen Inc
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This Medication Guide has been approved by the U.S. Food and Drug
Administration. Revised:
01/2021
MEDICATION GUIDE
Nplate® (N-plāt)
(romiplostim)
for injection
What is the most important information I should know about Nplate?
Nplate can cause serious side effects, including:
•
Worsening of a precancerous blood condition to a blood cancer
(leukemia). Nplate is not for use in
people with a precancerous condition called myelodysplastic syndromes
(MDS), or for any condition
other than immune thrombocytopenia (ITP). If you have MDS and receive
Nplate, your MDS
condition may worsen and become an acute leukemia. If MDS worsens to
become acute leukemia
you may die sooner from the acute leukemia.
•
Higher risk for blood clots.
○ You may have a higher risk of getting a blood clot if your
platelet count becomes high during
treatment with Nplate. You may have severe complications or die from
some forms of blood clots,
such as clots that spread to the lungs or that cause heart attacks or
strokes.
○ If you have a chronic liver disease, you may get blood clots in
the veins of your liver. This may
affect your liver function.
•
Injection of too much Nplate may cause a dangerous increase in your
blood platelet count and serious
side effects. Your healthcare provider may change your dose or stop
Nplate depending upon the
change in your blood platelet count. You must have blood platelet
counts done before you start,
during, and after Nplate therapy is stopped (see “How will I receive
Nplate?”).
See “What are the possible side effects of Nplate?” for other side
effects of Nplate.
What is Nplate?
•
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 r

उत्पाद विशेषताएं

NPLATE- ROMIPLOSTIM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
AMGEN INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NPLATE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NPLATE.
NPLATE (ROMIPLOSTIM) FOR INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2008
RECENT MAJOR CHANGES
Dosage and Administration (2.3)
02/2022
INDICATIONS AND USAGE
Nplate is a thrombopoietin receptor agonist indicated for the
treatment of thrombocytopenia in:
Adult patients with immune thrombocytopenia (ITP) who have had an
insufficient response to
corticosteroids, immunoglobulins, or splenectomy. (1.1)
Pediatric patients 1 year of age and older with ITP for at least 6
months who have had an insufficient
response to corticosteroids, immunoglobulins, or splenectomy. (1.1)
Nplate is indicated to increase survival in adults and in pediatric
patients (including term neonates) acutely
exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome
of Acute Radiation Syndrome
[HS-ARS]). (1.2)
Limitations of Use:
Nplate is not indicated for the treatment of thrombocytopenia due to
myelodysplastic syndrome (MDS)
or any cause of thrombocytopenia other than ITP.
Nplate should be used only in patients with ITP whose degree of
thrombocytopenia and clinical condition
increases the risk for bleeding.
Nplate should not be used in an attempt to normalize platelet counts.
(1)
DOSAGE AND ADMINISTRATION
Patients with Immune Thrombocytopenia (ITP)
Recommended Initial Dose: 1 mcg/kg once weekly as a subcutaneous
injection. Adjust dose based
on platelet response. (2.1)
Patients acutely exposed to myelosuppressive doses of radiation
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. (2.2)
See Full Prescribing Information for instructions on reconstitution,
preparation, and administration. (2.3)
DOSAGE FORMS AND STRENGTHS
For