FOLOTYN SIDE EFFECTS
- Generic Name: pralatrexate solution for intravenous injection
- Brand Name: Folotyn
- Drug Class: Antineoplastics, Antimetabolite
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 |
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| 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 |
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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 .