perts Understanding and Supporting Nplate and Patients) Program. Under the Nplate NEXUS Program, only prescribers and patients registered with the program are able to prescribe, administer, and receive Nplate. This program provides educational materials and a mechanism for the proper use of Nplate. To enroll in the Nplate NEXUS Program, call 1-877-Nplate1 (1-877-675-2831). Prescribers and patients are required to understand the risks of Nplate therapy. Prescribers are required to understand the information in the prescribing information and be able to:
Educate patients on the benefits and risks of treatment with Nplate, ensure that the patient receives the Medication Guide, instruct them to read it, and encourage them to ask questions when considering Nplate. Patients may be educated by the enrolled prescriber or a healthcare provider under that prescriber’s direction.
Review the Nplate NEXUS Program Healthcare Provider Enrollment Form, sign the form, and return the form according to Nplate NEXUS Program instructions.
Review the Nplate NEXUS Program Patient Enrollment Form, answer all questions, obtain the patient’s signature on the Nplate NEXUS Program Patient Enrollment Form, place the original signed form in the patient’s medical record, send a copy according to Nplate NEXUS Program instructions, and give a copy to the patient.
Report any serious adverse events associated with the use of Nplate to the Nplate NEXUS Program Call Center at 1-877-Nplate1 (1-877-675-2831) or to the FDA’s MedWatch Program at 1-800-FDA-1088.
Report serious adverse events observed in patients receiving Nplate, including events actively solicited at 6-month intervals.
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
Serious adverse reactions associated with Nplate in clinical studies were bone marrow reticulin deposition and worsening thrombocytopenia after Nplate discontinuation [see Warnings and Precautions (5.1, 5.2)].
The data described below reflect Nplate exposure to 271 patients with chronic ITP, aged 18 to 88, of whom 62% were female. Nplate was studied in two randomized, placebo-controlled, double-blind studies that were identical in design, with the exception that Study 1 eva luated nonsplenectomized patients with ITP and Study 2 eva luated splenectomized patients with ITP. Data are also reported from an open-label, single-arm study in which patients received Nplate over an extended period of time. Overall, Nplate was administered to 114 patients for at least 52 weeks and 53 patients for at least 96 weeks.
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In the placebo-controlled studies, headache was the most commonly reported adverse drug reaction, occurring in 35% of patients receiving Nplate and 32% of patients receiving placebo. Headaches were usually of mild or moderate severity. Table 2 presents adverse drug reactions from Studies 1 and 2 with a ≥ 5% higher patient incidence in Nplate versus placebo. The majority of these adverse drug reactions were mild to moderate in severity.
Table 2. Adverse Drug Reactions Identified in Two Placebo-Controlled Studies Preferred Term Nplate
(n = 84)
Placebo
(n = 41)
Arthralgia 26% 20%
Dizziness 17% 0%
Insomnia 16% |
