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Folotyn

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Folotyn

Side Effects
Interactions

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in the labeling:

The most common adverse reactions observed in patients with peripheral T-cell lymphoma (PTCL) treated with FOLOTYN were mucositis, thrombocytopenia, nausea, and fatigue.

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.

The safety of FOLOTYN was evaluated in 111 PTCL patients in a single-arm clinical study in which patients received a starting dose of 30 mg/m² once weekly for 6 weeks in 7-week cycles. The median duration of treatment was 70 days (range 1-540 days).

Most Frequent Adverse Reactions

Table 4 summarizes the most frequent adverse reactions, regardless of causality, using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE, version 3.0).

Table 4 : Adverse Reactions Occurring in PTCL Patients (Incidence ≥ 10% of patients)

Preferred Term N=111
Total Grade 3 Grade 4
N % N % N %
Any Adverse Event 111 100 48 43 34 31
  Mucositisa 78 70 19 17 4 4
  Thrombocytopeniab 45 41 15 14 21 19b
  Nausea 44 40 4 4 0 0
  Fatigue 40 36 5 5 2 2
  Anemia 38 34 17 15 2 2
  Constipation 37 33 0 0 0 0
  Pyrexia 36 32 1 1 1 1
  Edema 33 30 1 1 0 0
  Cough 31 28 1 1 0 0
  Epistaxis 29 26 0 0 0 0
  Vomiting 28 25 2 2 0 0
  Neutropenia 27 24 14 13 8 7
  Diarrhea 23 21 2 2 0 0
  Dyspnea 21 19 8 7 0 0
  Anorexia 17 15 3 3 0 0
  Hypokalemia 17 15 4 4 1 1
  Rash 17 15 0 0 0 0
  Pruritus 16 14 2 2 0 0
  Pharyngolaryngeal pain 15 14 1 1 0 0
  Liver function test abnormalc 14 13 6 5 0 0
  Abdominal pain 13 12 4 4 0 0
  Pain in extremity 13 12 0 0 0 0
  Back pain 12 11 3 3 0 0
  Leukopenia 12 11 3 3 4 4
  Night sweats 12 11 0 0 0 0
  Asthenia 11 10 1 1 0 0
  Tachycardia 11 10 0 0 0 0
  Upper respiratory tract infection 11 10 1 1 0 0
aStomatitis or mucosal inflammation of the gastrointestinal and genitourinary tracts.
bFive patients with platelets < 10,000/mcL
cAlanine aminotransferase, aspartate aminotransferase, and transaminases increased

Serious Adverse Events

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. Deaths from mucositis, febrile neutropenia, sepsis, and pancytopenia occurred in 1.2% of patients treated on all FOLOTYN trials at doses ranging from 30 to 325 mg/m².

Discontinuations

Twenty-three percent of patients (n = 25) discontinued treatment with FOLOTYN due to adverse reactions. The adverse reactions reported most frequently as the reason for discontinuation of treatment were mucositis (6%, n = 7) and thrombocytopenia (5%, n = 5).

Dose Modifications

The target dose of FOLOTYN was 30 mg/m² once weekly for 6 weeks in 7-week cycles. The majority of patients (69%, n = 77) remained at the target dose for the duration of treatment. Overall, 85% of scheduled doses were administered.

Post Marketing Experience

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, sometimes fatal, has been reported during post-marketing use of FOLOTYN. Fatal cases have been reported following the first dose of FOLOTYN, including when a reduced dose is given, and have been reported in patients with end-stage renal disease undergoing dialysis [see WARNINGS AND PRECAUTIONS, Use In Specific Populations, and CLINICAL PHARMACOLOGY].

Read the Folotyn (pralatrexate solution for intravenous injection) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No formal clinical assessments of pharmacokinetic drug-drug interactions between FOLOTYN and other drugs have been conducted. The effect of co-administration of the uricosuric drug probenecid (an inhibitor of multiple transporter systems including the multidrug resistance-associated protein 2 (MRP2) efflux transporter) on pralatrexate pharmacokinetics was investigated in a Phase 1 clinical study. Co-administration of increasing doses of probenecid resulted in delayed clearance of pralatrexate and a commensurate increase in exposure [see CLINICAL PHARMACOLOGY].

When administering FOLOTYN to patients receiving probenecid or other drugs that may affect relevant transporter systems (eg, NSAIDs), monitor patients closely for signs of systemic toxicity due to increased drug exposure.

Read the Folotyn Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 6/7/2012
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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