Note: This document contains side effect information about pemetrexed. Some dosage forms listed on this page may not apply to the brand name Pemfexy.

Applies to pemetrexed: intravenous powder for solution, intravenous solution.

Serious side effects of Pemfexy

Along with its needed effects, pemetrexed (the active ingredient contained in Pemfexy) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking pemetrexed:

More common

• Black, tarry stools
• bleeding gums
• chest pain
• chills
• cough
• fever
• loss of coordination
• lower back or side pain
• painful or difficult urination
• pains in the chest, groin, or legs, especially calves of the legs
• pale skin
• pinpoint red spots on the skin
• severe headaches of sudden onset
• sore throat
• sudden onset of slurred speech
• sudden vision changes
• swollen glands
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Bloody urine or bloody stools
• chest tightness
• decreased frequency or amount of urine
• fainting or loss of consciousness
• fast or irregular breathing
• increased blood pressure
• increased thirst
• itching, skin rash
• loss of appetite
• nausea
• swelling of the eyes, eyelids, face, fingers, or lower legs
• vomiting
• weight gain

Incidence not known

• Blistering, peeling, or loosening of the skin
• joint or muscle pain
• pain and redness of the skin in the area of earlier radiation treatment
• red skin lesions, often with a purple center
• red, irritated eyes
• stomach cramps, tenderness, or pain
• watery diarrhea

Other side effects of Pemfexy

Some side effects of pemetrexed may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Burning, tingling, numbness, or pain in the hands, arms, feet, or legs
• confusion
• cough
• diarrhea
• difficulty having a bowel movement
• difficulty with moving
• difficulty with swallowing
• discouragement
• dizziness
• dry mouth
• feeling sad or empty
• hair loss
• headache
• heartburn
• hoarseness
• increase in heart rate
• irritability
• lightheadedness
• loss of interest or pleasure
• mood changes
• muscle ache, cramp, or stiffness
• pain or burning in the throat
• pain produced by swallowing
• rapid breathing
• sensation of pins and needles
• stabbing pain
• stuffy or runny nose
• sunken eyes
• swelling or inflammation of the mouth
• swollen joints
• thinning of the hair
• thirst
• tiredness
• trouble concentrating
• trouble sleeping
• weight loss
• wrinkled skin

For Healthcare Professionals

Applies to pemetrexed: intravenous powder for injection, intravenous solution.

General

The most common adverse reactions reported with this drug were: fatigue, nausea, and anorexia (when administered as a single agent); vomiting, neutropenia, anemia, stomatitis/pharyngitis, thrombocytopenia, and constipation (when administered with cisplatin); and fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, and pyrexia (when administered with pembrolizumab and platinum chemotherapy).^[Ref]

Cardiovascular

Very common (10% or more): Hypertension (up to 11%)

Common (1% to 10%): Thrombosis/embolism, cardiac failure, arrhythmia

Uncommon (0.1% to 1%): Serious cardiovascular events (including myocardial infarction, angina pectoris), angina, myocardial infarction, coronary artery disease, supraventricular arrhythmia

Frequency not reported: Ventricular tachycardia

Postmarketing reports: Peripheral ischemia (sometime leading to extremity necrosis)

Serious cardiovascular and cerebrovascular events (including myocardial infarction, angina pectoris, cerebrovascular accident, transient ischemic attack) have been uncommonly reported during clinical studies with this drug, usually when given in combination with another cytotoxic agent. Most of the patients experiencing such events had preexisting cardiovascular risk factors.

Dermatologic

Very common (10% or more): Rash (includes genital rash, rash, generalized rash, macular rash, maculopapular rash, papular rash, pruritic rash, pustular rash; up to 25%), rash/desquamation (up to 14%), alopecia (up to 12%), skin exfoliation

Common (1% to 10%): Pruritus/itching, erythema multiforme, urticaria, hyperpigmentation

Rare (0.01% to 0.1%): Erythema, recall phenomenon

Very rare (less than 0.01%): Dermo-hypodermitis, pemphigoid, bullous dermatitis, acquired epidermolysis bullosa, erythematous edema (mainly of the lower limbs), pseudocellulitis, dermatitis, eczema, prurigo

Postmarketing reports: Serious and fatal bullous skin conditions, Stevens-Johnson syndrome (in some cases fatal), toxic epidermal necrolysis (in some cases fatal), radiation recall, hyperpigmentation, infectious/noninfectious disorders of the dermis/hypodermis/subcutaneous tissue (e.g., acute bacterial dermo-hypodermitis, pseudocellulitis, dermatitis)

Gastrointestinal

Very common (10% or more): Nausea (up to 82.1%), vomiting (up to 57%), constipation (up to 35%), diarrhea (up to 31%), stomatitis/pharyngitis (up to 23.2%), diarrhea (without colostomy; up to 12.4%), pharyngitis, stomatitis

Common (1% to 10%): Dyspepsia/heartburn, mucositis/stomatitis, abdominal pain

Uncommon (0.1% to 1%): Esophagitis, radiation esophagitis, colitis (including intestinal/rectal bleeding [sometimes fatal], intestinal perforation, intestinal necrosis, typhlitis), rectal hemorrhage, gastrointestinal hemorrhage, intestinal perforation

Frequency not reported: Gastrointestinal obstruction, severe esophagitis (resulting in hospitalization)

Postmarketing reports: Colitis, pancreatitis

Hematologic

Very common (10% or more): Anemia (up to 85%), lymphopenia (up to 64%), neutropenia (up to 56%), decreased neutrophils/granulocytes (up to 56%), decreased leukocytes (up to 53%), decreased hemoglobin (up to 33%), thrombocytopenia (up to 30%), decreased platelets (up to 23.2%), RBC transfusions required (up to 13%), erythropoiesis stimulating agents required (up to 12%), leukopenia

Common (1% to 10%): Febrile neutropenia, neutropenic infection, transfusions required (primarily RBC transfusions), platelet transfusions required, granulocyte colony stimulating factors required

Uncommon (0.1% to 1%): Pancytopenia

Rare (0.01% to 0.1%): Autoimmune hemolytic anemia

Postmarketing reports: Immune-mediated hemolytic anemia

Hepatic

Very common (10% or more): Increased ALT (up to 47%), increased AST (up to 47%)

Common (1% to 10%): Increased GGT

Rare (0.01% to 0.1%): Hepatitis

Hypersensitivity

Common (1% to 10%): Allergic reaction/hypersensitivity

Postmarketing reports: Anaphylactic shock

Metabolic

Very common (10% or more): Hyperglycemia (up to 63%), hypoalbuminemia (up to 39%), hyponatremia (up to 32%), hypophosphatemia (up to 30%), decreased appetite (up to 30%), anorexia (up to 27%), hypocalcemia (up to 24%), hyperkalemia (up to 24%), hypokalemia (up to 21%)

Common (1% to 10%): Dehydration

Nervous system

Very common (10% or more): Peripheral sensory neuropathy (up to 10.1%)

Common (1% to 10%): Taste disturbance/disorder, peripheral motor neuropathy, dizziness

Uncommon (0.1% to 1%): Serious cerebrovascular events (including cerebrovascular accident, transient ischemic attack), cerebrovascular accident, ischemic stroke, intracranial hemorrhage

Frequency not reported: Syncope

Ocular

Common (1% to 10%): Conjunctivitis, ocular surface disease, increased lacrimation, dry eye, keratoconjunctivitis sicca, eyelid edema

Other

Very common (10% or more): Fatigue (includes asthenia, fatigue; up to 58%), increased alkaline phosphatase (up to 29%), pyrexia (up to 20%), infection (with and without neutropenia)

Common (1% to 10%): Asthenia, pain, edema, chest pain, infection (with Grade 3 to 4 neutropenia), sepsis (with or without neutropenia [including fatal cases]), infection (without neutropenia), fever (without neutropenia), mucosal inflammation

Postmarketing reports: Edema

Psychiatric

Frequency not reported: Depression

Renal

Very common (10% or more): Increased blood creatinine (up to 37%), decreased CrCl (up to 16%)

Common (1% to 10%): Renal failure, acute kidney injury, renal disorders (includes increased serum/blood creatinine, decreased GFR, renal failure, renal/genitourinary - other), decreased GFR

Uncommon (0.1% to 1%): Acute renal failure

Postmarketing reports: Nephrogenic diabetes insipidus, renal tubular necrosis

Respiratory

Very common (10% or more): Cough (up to 28%), dyspnea (up to 26%)

Common (1% to 10%): Pneumonitis, pneumonia

Uncommon (0.1% to 1%): Interstitial pneumonitis (with respiratory insufficiency [sometimes fatal]), pulmonary embolism, radiation pneumonitis

Postmarketing reports: Interstitial pneumonitis, radiation pneumonitis