INDICATIONS

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. Nplate® is indicated for the treatment of thrombocytopenia in 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 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 increase the risk for bleeding. Nplate® should not be used in an attempt to normalize platelet counts.

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PRESCRIBING INFORMATION INDICATIONS IMPORTANT SAFETY INFORMATION VISIT PATIENT SITE

Established Safety Profile Without Food Restrictions

Once-weekly, in-office, subcutaneous injection1

Only TPO-RA that can be taken with or without food

Only TPO-RA that can be taken with or without food and without any dietary restrictions

  • Including bread, milk and cereal, ice cream, cheese, tofu, calcium-fortified orange juice, yogurt, pizza, and leafy green vegetables1
No daily pill reminders

No need to wonder if your patient is taking a pill every day1-4

Established Safety Profile

5 years

No new safety signals observed up to 5 years of continuous treatment5

No liver monitoring required

No liver monitoring and no known drug interactions1,6

  • No interactions with other drugs (eg, statins, multivitamins, and CYP enzyme inhibitors or inducers*)1

*The following is not intended to be a comprehensive list and includes examples of CYP3A4 and CYP2C9 inhibitors and inducers. CYP3A4 inhibitors include amiodarone, aprepitant, ciprofloxacin, clarithromycin, haloperidol, ketoconazole, metoprolol, paroxetine, risperidone, ritonavir, tramadol, and verapamil. CYP3A4 inducers include griseofulvin and St John’s wort. CYP2C9 inhibitors include fluconazole, fluoxetine, metronidazole, and trimethoprim/sulfamethoxazole. CYP2C9 inducers include carbamazepine, phenobarbital, phenytoin, and rifampin.7

Pivotal Trials (Pooled)

Pediatric Safety Profile Was Established in a 12- and 24-Week Trial1,†

Common adverse reactions from 2 placebo-controlled pediatric studies1,‡

                                        
ADVERSE REACTIONS BY BODY SYSTEM NPLATE® (%)
(n = 59) 		PLACEBO (%)
(n = 24)
Infections and Infestations
Upper Respiratory Tract Infection 18 (31%) 6 (25%)
Ear Infection 3 (5%) 0 (0.0%)
Gastroenteritis 3 (5%) 0 (0.0%)
Sinusitis 3 (5%) 0 (0.0%)
Respiratory, Thoracic, and Mediastinal Disorders
Oropharyngeal Pain 15 (25%) 1 (4%)
Gastrointestinal Disorders
Diarrhea 12 (20%) 3 (13%)
Abdominal Pain Upper 8 (14%) 1 (4%)
Skin and Subcutaneous Tissue Disorders
Rash 9 (15%) 2 (8%)
Purpura 4 (7%) 0 (0.0%)
Urticaria 3 (5%) 0 (0.0%)
General Disorders and Administration Site Conditions
Pyrexia 14 (24%) 2 (8%)
Peripheral Swelling 4 (7%) 0 (0.0%)
Injury, Poisoning, and Procedural Complications
Contusion 24 (41%) 8 (33%)
  • Adverse reactions with an incidence of ≥ 25% in the 2 placebo-controlled trials were contusion, upper respiratory tract infection, and oropharyngeal pain.1

Nplate® was studied in pediatric patients with ITP in a Phase 3 study and Phase 1/2 study.

Phase 1/2 study (N = 22):

Nplate® was studied in patients diagnosed with ITP at least 6 months prior to enrollment with a platelet count ≤ 30 x 109/L1

  • Patients were stratified by age and randomized (3:1) to receive (1 mcg/kg subcutaneously weekly) Nplate® or placebo1
  • Over a 12-week treatment period dose was titrated up to a maximum of 10 mcg/kg weekly of either Nplate® or placebo in an effort to maintain a target platelet count of ≥ 50–250 x 109/L

†The 12-week trial was the phase 1/2 trial. The 24-week trial was the phase 3 trial.

‡≥ 5% incidence and ≥ 5% more frequent in the Nplate® arm.

Long-Term Extension Data

Nplate® Was Studied in a Long-Term Extension Study in Pediatric Patients8

The most frequently occurring (> 45%) adverse events were headache (58.5%), contusion (50.8%), epistaxis, upper respiratory tract infection and vomiting (49.2% each), cough and oropharyngeal pain (46.2% each). The most frequently reported (> 5%) Grade 3 or 4 adverse events were thrombocytopenia (9.2%) and headache (6.2%).

ITP, Immune thrombocytopenia.

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Important Safety Information

Risk of Progression of Myelodysplastic Syndromes to Acute Myelogenous Leukemia

  • In Nplate® (romiplostim) clinical trials of patients with myelodysplastic syndromes (MDS) and severe thrombocytopenia, progression from MDS to acute myelogenous leukemia (AML) has been observed.
  • Nplate® is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than ITP.

Thrombotic/Thromboembolic Complications

  • Thrombotic/thromboembolic complications have resulted from increases in platelet counts with Nplate® use in the ITP population, including deep vein thrombosis (1.4%), pulmonary embolism (1.2%) and myocardial infarction (0.8%). Other thrombotic events including transient ischemic attack have been reported. These events have occurred regardless of platelet counts. Portal vein thrombosis has been reported in patients both with and without chronic liver disease receiving Nplate®.
  • To minimize the risk for thrombotic/thromboembolic complications, do not use Nplate® in an attempt to normalize platelet counts. Follow the dose adjustment guidelines to achieve and maintain a platelet count of ≥ 50 x 109/L.

Loss of Response to Nplate®

  • Hyporesponsiveness or failure to maintain a platelet response with Nplate® should prompt a search for causative factors, including neutralizing antibodies to Nplate®.
  • Discontinue Nplate® if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks at the highest weekly dose of 10 mcg/kg.
Adverse Reactions
Adult ITP
  • In the placebo-controlled trials of adult ITP patients, headache was the most commonly reported adverse drug reaction, occurring in 35% of patients receiving Nplate® and 32% of patients receiving placebo. Adverse drug reactions in adults with a ≥ 5% higher patient incidence in Nplate® versus placebo were Arthralgia (26%, 20%), Dizziness (17%, 0%), Insomnia (16%, 7%), Myalgia (14%, 2%), Pain in Extremity (13%, 5%), Abdominal Pain (11%, 0%), Shoulder Pain (8%, 0%), Dyspepsia (7%, 0%), and Paresthesia (6%, 0%).
  • The safety profile of Nplate® was similar across patients, regardless of ITP duration. The following adverse reactions (at least 5% incidence and at least 5% more frequent with Nplate® compared with placebo or standard of care) occurred in Nplate® patients with ITP duration up to 12 months: bronchitis, sinusitis, vomiting, arthralgia, myalgia, headache, dizziness, diarrhea, upper respiratory tract infection, cough, nausea and oropharyngeal pain. The adverse reaction of thrombocytosis occurred with an incidence of 2% in adults with ITP duration up to 12 months.
Pediatric ITP
  • The most common adverse reactions experienced by ≥ 5% of patients receiving Nplate® with ≥ 5% higher incidence in the Nplate® arm across the two placebo-controlled trials were contusion (41%), upper respiratory tract infection (31%), oropharyngeal pain (25%), pyrexia (24%), diarrhea (20%), rash (15%), and upper abdominal pain (14%).
  • In pediatric patients of age ≥ 1 year receiving Nplate® for ITP, adverse reactions with an incidence of ≥ 25% in the two randomized trials were: contusion (41%), upper respiratory tract infection (31%), and oropharyngeal pain (25%).
  • In a long term, single arm, open label pediatric safety study, headache occurred in 78/203 patients (38%); the incidence rates of other adverse reactions were similar to those reported in the placebo-controlled studies.

Nplate® administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. This formation may improve upon discontinuation of Nplate®. In a clinical trial, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate® therapy.

INDICATIONS

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. Nplate® is indicated for the treatment of thrombocytopenia in 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 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 increase the risk for bleeding. Nplate® should not be used in an attempt to normalize platelet counts.

Please see full Prescribing Information and Medication Guide.

Important Safety Information

Risk of
Progression of Myelodysplastic Syndromes to Acute Myelogenous Leukemia

  • In Nplate® (romiplostim) clinical trials of patients with myelodysplastic syndromes (MDS) and severe thrombocytopenia, progression from MDS to acute myelogenous leukemia (AML) has been observed.
  • Nplate® is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than ITP.

Thrombotic/Thromboembolic Complications

  • 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®.
  • To minimize the risk for thrombotic/thromboembolic complications, do not use Nplate® in an attempt to normalize platelet counts. Follow the dose adjustment guidelines to achieve and maintain a platelet count of ≥ 50 x 109/L.

Loss of Response to Nplate®

References: 1. Nplate® (romiplostim) prescribing information, Amgen. 2. Promacta® (eltrombopag) full Prescribing Information, Novartis. 3. Doptelet® (avatrombopag) full Prescribing Information, Sobi. 4. Tavalisse® (fostamatinib disodium hexahydrate) full Prescribing Information, Rigel. 5. Kuter DJ, Bussel JB, Newland A, et al. Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy. Br J Haematol. 2013;161(3):411-423. 6. Data on file, Amgen; Clinical Study Report 20080435; 2014. 7. Gilani B, Cassagnol M. Biochemistry, Cytochrome P450. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; January 2024. https://www.ncbi.nlm.nih.gov/books/NBK557698/. 8. Data on file, Amgen; Pediatric long-term data 20090340; 2017. 9. Data on file, Amgen; Number of patients treated with Nplate® from launch through to June 2023; Updated 2023.