FOLOTYN SIDE EFFECTS

  • Generic Name: pralatrexate solution for intravenous injection
  • Brand Name: Folotyn
  • Drug Class: Antineoplastics, Antimetabolite
Last updated on MDtodate: 10/6/2022

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Myelosuppression
  • Mucositis]
  • Dermatologic Reactions
  • Tumor Lysis Syndrome
  • Hepatic Toxicity

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Peripheral T-cell Lymphoma

The safety of FOLOTYN was evaluated in Study PDX-008. Patients received FOLOTYN 30 mg/m² once weekly for 6 weeks in 7-week cycles. The median duration of treatment was 70 days (range: 1 day to 1.5 years). The majority of patients (69%, n = 77) remained at the target dose for the duration of treatment. Overall, 85% of scheduled doses were administered.

Forty-four percent of patients (n = 49) experienced a serious adverse event while on study or within 30 days after their last dose of FOLOTYN. The most common serious adverse events (> 3%), regardless of causality, were pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia. One death from cardiopulmonary arrest in a patient with mucositis and febrile neutropenia was reported in this trial. Across clinical trials, deaths from mucositis, febrile neutropenia, sepsis, and pancytopenia occurred in 1.2% of patients who received doses ranging from 30 mg/m² to 325 mg/m².

Twenty-three percent of patients (n = 25) discontinued treatment with FOLOTYN due to adverse reactions. The most frequent adverse reactions reported as the reason for discontinuation of treatment were mucositis (6%) and thrombocytopenia (5%).

The most common adverse reactions (> 35%) were mucositis, thrombocytopenia, nausea, and fatigue.

Table 1 summarizes the adverse reactions in Study PDX-008.

Table 1 : Adverse Reactions in (≥ 10%) in Patients Who Received FOLOTYN in Study PDX-008

FOLOTYN
N=111
All Grades (%) Grade 3 (%) Grade 4 (%)
Any Adverse Reaction 100 43 31
Mucositisa 70 17 4
Thrombocytopeniab 41 14 19b
Nausea 40 4 0
Fatigue 36 5 2
Anemia 34 15 2
Constipation 33 0 0
Pyrexia 32 1 1
Edema 30 1 0
Cough 28 1 0
Epistaxis 26 0 0
Vomiting 25 2 0
Neutropenia 24 13 7
Diarrhea 21 2 0
Dyspnea 19 7 0
Hypokalemia 15 4 1
Anorexia 15 3 0
Rash 15 0 0
Pruritus 14 2 0
Pharyngolaryngeal pain 14 1 0
Liver function test abnormalc 13 5 0
Abdominal pain 12 4 0
Pain in extremity 12 0 0
Leukopenia 11 3 4
Back pain 11 3 0
Night sweats 11 0 0
Asthenia 10 1 0
Upper respiratory tract infection 10 1 0
Tachycardia 10 0 0
a Mucositis includes stomatitis or mucosal inflammation of the gastrointestinal and genitourinary tracts.
b Five patients with platelets < 10,000/mcL.
c Liver function test abnormal includes increased ALT, increased AST, and increased transaminases

 

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of FOLOTYN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Dermatologic Reactions: Toxic epidermal necrolysis.

 

SRC: NLM .