Folotyn
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Folotyn
Folotyn Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Folotyn in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- taste loss, mouth pain, redness or ulcers, or white-yellow mouth sores;
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
- fever, chills, body aches, flu symptoms, rapid heart rate, rapid and shallow breathing, fainting;
- pale skin, feeling light-headed or short of breath, trouble concentrating;
- weakness, decreased sweating, hot or dry skin; or
- confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling.
Less serious side effects may include:
- nausea, vomiting, loss of appetite;
- diarrhea, constipation;
- tired feeling;
- cough;
- swelling; or
- mild rash or itching.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Folotyn (Pralatrexate Solution for Intravenous Injection) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Folotyn Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do have serious side effects.
Serious skin reactions can occur. Tell your doctor immediately if you develop rash, peeling, sores or blisters on the skin.
Tell your doctor immediately if any of these unlikely but serious side effects occur: signs of infection (such as fever, cough, sore throat, chills), easy bleeding/bruising, dehydration, feeling weak, looking pale, shortness of breath.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Folotyn (Pralatrexate Solution for Intravenous Injection)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Folotyn FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
The following serious adverse reactions are described below and elsewhere in the labeling:
- Bone Marrow Suppression [see WARNINGS AND PRECAUTIONS]
- Mucositis [see WARNINGS AND PRECAUTIONS]
- Dermatologic Reactions [see WARNINGS AND PRECAUTIONS]
- Tumor Lysis Syndrome [see WARNINGS AND PRECAUTIONS]
- Hepatic Toxicity [see WARNINGS AND PRECAUTIONS]
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 entire FDA prescribing information for Folotyn (Pralatrexate Solution for Intravenous Injection) »
Additional Folotyn Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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