EFFICACY & SAFETY

Rapid response: As early as Week 1^1,2

Platelet levels ≥50,000/mcL (PETIT)^1,2

In the PETIT pivotal trial:

• Primary end point: The proportion of patients who achieved a response (defined as platelet count ≥50,000/mcL in absence of rescue therapy) at least once between Weeks 1 and 6 of the randomized, double-blind period^1,2

• At baseline, ~51% of patients had platelet counts ≤15,000/mcL¹

• At Week 1, 24% of patients receiving PROMACTA achieved platelet levels ≥50,000/mcL vs 14% with placebo²

Study Design

The PETIT trial was a phase 2, 7-week, double-blind trial in children ≥1 year of age with relapsed or refractory ITP, followed by an open-label period of up to 24 weeks when patients from both arms were eligible to receive PROMACTA.^1,2 Sixty-seven patients were randomized 2:1 to PROMACTA (n=45) or placebo (n=22) and permitted to use maintenance therapy, including (but not limited to) steroids, azathioprine, danazol, CsA, and mycophenolate mofetil.^1,2 Platelet response was evaluated overall and for 3 age cohorts: 1) 12 to 17 years, 2) 6 to 11 years, and 3) 1 to 5 years.¹

Durable response: Levels maintained for ≥6 weeks^1,3,*

Platelet levels ≥50,000/mcL (PETIT 2)^1,3

In the PETIT 2 pivotal trial:

• Primary end point: The proportion of patients who achieved a response (defined as platelet count ≥50,000/mcL in absence of rescue therapy) for at least 6 of the 8 weeks between Weeks 5 and 12 of the randomized, double-blind period^1,3
• At baseline, ~62% of patients had platelet counts ≤15,000/mcL¹
   

Study Design

The PETIT 2 trial was a phase 3, 13-week, double-blind trial to assess the efficacy and safety of PROMACTA in children ≥1 year of age with relapsed or refractory ITP, followed by a 24-week open-label extension phase when patients from both arms were eligible to receive PROMACTA.^1,3 Ninety-two patients were randomized 2:1 to PROMACTA (n=63) or placebo (n=29) and permitted to use maintenance therapy, including steroids, IVIg, CsA, mycophenolate, azathioprine, and dapsone.^1,3 Patients were permitted to reduce or discontinue baseline ITP therapy only during the open-label phase of the trial. Platelet response was evaluated overall and for 3 age cohorts: 1) 12 to 17 years, 2) 6 to 11 years, and 3) 1 to 5 years.¹

*In the extension phase of the study, platelet levels ≥50,000/mcL were maintained for a mean of 8.6 weeks and a median of 6 weeks.³

Safety established in 2 pediatric trials with patients aged 1 year and older¹

Pooled results from PETIT and PETIT 2¹

^aThe adverse events listed above were pooled from the placebo-controlled phases of the PETIT and PETIT 2 clinical trials.
^bIncludes adverse reactions or laboratory abnormalities 3 × ULN.

• During the randomized period of PETIT: 6.8% of patients experienced grade 3 and 4.5% of patients experienced grade 4 adverse events during the randomized period²

• During the randomized period of PETIT 2: 12.7% of patients experienced grade 3 and no patients experienced grade 4 adverse events during the randomized period³

DOSING & ADMINISTRATION

Convenient once-daily oral dosing: At home, at school, or on the go¹

PROMACTA can be taken without food or with food low in calcium (≤50 mg)

• PROMACTA should be taken at least 2 hours before or 4 hours after medications such as antacids and mineral supplements or foods high in calcium

• PROMACTA can be taken any time of day, at the same time each day

• No need for weekly office visits for injections and with PROMACTA tablets, there is less unused medication to discard 

Two oral formulations: Dosing flexibility, even for patients who have difficulty swallowing a pill¹

Recommended starting dose for patients with persistent or chronic ITP¹

^a Except in patients who are of East-/Southeast-Asian ancestry or who have mild to severe hepatic impairment (Child-Pugh class A, B, C).

• For patients aged 6 years and older who are of Asian ancestry OR who have mild to severe hepatic impairment, initiate PROMACTA at a reduced dose of 25 mg once daily 

• For patients aged 6 years and older who are of Asian ancestry WITH hepatic impairment, consider initiating at a reduced dose of 12.5 mg once daily

• PROMACTA has a maximum dosage of 75 mg per day

No weekly injection required¹

Oral Suspension

PROMACTA for oral suspension kits

• Available to order in boxes of 12.5-mg and 25-mg packets
• Request a Demonstration Kit through your local representative

ALT, alanine aminotransferase; AST, aspartate aminotransferase; CsA, cyclosporine A; ITP, immune thrombocytopenia; IVIg, intravenous immunoglobulin; ULN, upper limit of normal.