Applies to fosaprepitant: intravenous powder for solution.

Serious side effects of Fosaprepitant

Along with its needed effects, fosaprepitant 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 fosaprepitant:

More common

• Black, tarry stools
• blurred vision
• chest tightness
• chills
• confusion
• cough
• decreased urination
• difficult or labored breathing
• dizziness
• dry mouth
• fainting
• fever
• increase in heart rate
• lightheadedness
• lower back or side pain
• nervousness
• pain, swelling, or redness at the injection site
• painful or difficult urination
• pale skin
• pounding in the ears
• rapid breathing
• slow or fast heartbeat
• sore throat
• sunken eyes
• tenderness, swelling, warmth, or skin discoloration at the injection site
• thirst
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• wrinkled skin

Less common

• Hard lump at the injection site

Rare

• Blood in the urine
• changes in patterns and rhythms of speech
• changes in skin color
• chest pain or discomfort
• fast, slow, irregular, pounding, or racing heartbeat or pulse
• general feeling of discomfort or illness
• headache
• increased sweating
• increased thirst
• lightheadedness, dizziness, or fainting
• loss of consciousness
• muscle pain or cramps
• nausea
• pain, tenderness, or swelling of the foot or leg
• seizures
• slurred speech
• swelling
• swelling of the face, ankles, or hands
• trouble with speaking
• trouble breathing
• vomiting

Incidence not known

• Diarrhea
• difficulty with swallowing
• hives or welts, itching
• joint pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• redness of the skin

Other side effects of Fosaprepitant

Some side effects of fosaprepitant 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

• Belching
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• continuing ringing or buzzing or other unexplained noise in ears
• difficulty having a bowel movement
• dizziness
• feeling of indigestion
• hair loss or thinning of the hair
• hearing loss
• hiccups
• indigestion
• lack or loss of strength
• loss of appetite
• pain in the chest below the breastbone
• stomach discomfort, upset, or pain
• swelling or inflammation of the mouth
• weight loss

Less common

• Feeling of warmth
• pain or discomfort in chest, upper stomach, or throat
• redness of the face, neck, arms, and occasionally, upper chest
• sudden sweating
• unusually warm skin

Rare

• Abnormal dreams
• blemishes on the skin
• bumps on the skin
• burning, dry, or itching eyes
• change in taste
• change in walking and balance
• clumsiness or unsteadiness
• confusion about identity, place, and time
• difficulty with moving
• discharge, excessive tearing
• excess air or gas in the stomach
• extreme thirst
• false or unusual sense of well-being
• flushed, dry skin
• frequent urination
• fruit-like breath odor
• full feeling
• heartburn
• increased hunger
• increased sensitivity of the skin to sunlight
• increased urination
• increased volume of pale, dilute urine
• muscle ache, cramp, stiffness, or weakness
• oily skin
• passing gas
• pimples
• redness or other discoloration of the skin
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• severe constipation
• severe sunburn
• sleepiness
• stomach distension
• sweating
• swollen joints
• trouble performing routine tasks
• trouble sleeping
• unexplained weight loss
• unusual drowsiness, dullness, or feeling of sluggishness
• weight gain
• white patches with diaper rash

For Healthcare Professionals

Applies to fosaprepitant: intravenous powder for injection.

General

The most common side effects reported were fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, and pain in extremity.

Because fosaprepitant is converted to aprepitant, side effects associated with aprepitant may be expected to occur with this drug. The manufacturer product information for aprepitant should be consulted.^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Increased blood pressure, flushing, hot flush, palpitations, thrombophlebitis

Frequency not reported: Hypotension

Aprepitant:

-Uncommon (0.1% to 1%): Palpitations, hot flush/flushing

-Rare (0.01% to 0.1%): Bradycardia, cardiovascular disorder

Dermatologic

Uncommon (0.1% to 1%): Erythema

Postmarketing reports: Pruritus, rash, urticaria, Stevens-Johnson syndrome/toxic epidermal necrolysis

Aprepitant:

-Uncommon (0.1% to 1%): Acne, rash

-Rare (0.01% to 0.1%): Hyperhidrosis, photosensitivity reaction, pruritic rash, seborrhea, skin lesion, Stevens-Johnson syndrome/toxic epidermal necrolysis

-Frequency not reported: Pruritus, urticaria, angioedema

Gastrointestinal

Constipation and subileus occurred at higher doses of aprepitant.

Very common (10% or more): Diarrhea (up to 13%)

Common (1% to 10%): Constipation, dyspepsia

Uncommon (0.1% to 1%): Abdominal distention, abdominal pain, upper abdominal pain, oral candidiasis

Aprepitant:

-Common (1% to 10%): Constipation, dyspepsia, diarrhea, eructation

-Uncommon (0.1% to 1%): Abdominal pain, gastroesophageal reflux disease, nausea, vomiting, dry mouth, flatulence

-Rare (0.01% to 0.1%): Duodenal ulcer perforation, abdominal distension, hard feces, neutropenic colitis, stomatitis

-Frequency not reported: Upper abdominal pain, abnormal bowel sounds, stomach discomfort, subileus

Genitourinary

Common (1% to 10%): Urinary tract infection

Aprepitant:

-Uncommon (0.1% to 1%): Dysuria

-Rare (0.01% to 0.1%): Glucose urine present, pollakiuria, RBCs urine positive, increased urine output

Hematologic

Common (1% to 10%): Anemia, leukopenia, neutropenia

Frequency not reported: Thrombocytopenia

Aprepitant:

-Common (1% to 10%): Decreased hemoglobin

-Uncommon (0.1% to 1%): Febrile neutropenia, anemia

-Rare (0.01% to 0.1%): Decreased neutrophil count

Hepatic

Aprepitant:

-Common (1% to 10%): Increased ALT, increased AST

-Frequency not reported: Increased blood bilirubin

Hypersensitivity

Frequency not reported: Immediate hypersensitivity reactions (including flushing, erythema, dyspnea, anaphylactic reactions/anaphylactic shock)

Postmarketing reports: Hypersensitivity reactions (including anaphylactic reactions/anaphylaxis, anaphylactic shock), immediate hypersensitivity/anaphylactic reactions during infusion (including flushing, erythema, rash, chest tightness, wheezing, dyspnea)

Local

Infusion site reactions occurred in 2.2% of patients treated with this drug compared to 0.6% of patients treated with ondansetron and dexamethasone (standard therapy). These reactions included infusion-site pain, injection-site irritation, vessel puncture-site pain, and infusion-site thrombophlebitis.

Common (1% to 10%): Infusion-site reactions, infusion site pain

Uncommon (0.1% to 1%): Infusion-site erythema, infusion-site induration, infusion-site pruritus, infusion-site thrombophlebitis, injection-site irritation, vessel puncture-site pain

Metabolic

Uncommon (0.1% to 1%): Decreased appetite

Aprepitant:

-Common (1% to 10%): Decreased appetite

-Rare (0.01% to 0.1%): Polydipsia

-Frequency not reported: Increased blood glucose

Musculoskeletal

Common (1% to 10%): Pain in extremity

Aprepitant:

-Rare (0.01% to 0.1%) Muscular weakness, muscle spasms

Nervous system

Ifosfamide-induced neurotoxicity has been reported after coadministration of this drug and ifosfamide.

Common (1% to 10%): Peripheral neuropathy

Frequency not reported: Syncope

Postmarketing reports: Ifosfamide-induced neurotoxicity

Aprepitant:

-Common (1% to 10%): Headache

-Uncommon (0.1% to 1%): Dizziness, somnolence

-Rare (0.01% to 0.1%): Cognitive disorder, dysgeusia, lethargy, tinnitus

-Frequency not reported: Dysarthria, hypoesthesia, sensory disturbance

Ocular

Aprepitant:

-Rare (0.01% to 0.1%): Conjunctivitis

-Frequency not reported: Miosis, reduced visual acuity

Other

Very common (10% or more): Fatigue (up to 15%)

Common (1% to 10%): Asthenia

Aprepitant:

-Common (1% to 10%): Asthenia, fatigue

-Uncommon (0.1% to 1%): Malaise, increased blood alkaline phosphatase

-Rare (0.01% to 0.1%): Candidiasis, staphylococcal infection, gait disturbance, decreased blood sodium, weight decreased, chest discomfort, edema

-Frequency not reported: Decreased blood albumin, decreased blood potassium

Psychiatric

Aprepitant:

-Uncommon (0.1% to 1%): Anxiety

-Rare (0.01% to 0.1%): Disorientation, euphoric mood

-Frequency not reported: Insomnia

Respiratory

Uncommon (0.1% to 1%): Cough, oropharyngeal pain, throat irritation

Frequency not reported: Dyspnea

Aprepitant:

-Common (1% to 10%): Hiccups

-Rare (0.01% to 0.1%): Postnasal drip, sneezing, oropharyngeal pain, cough, throat irritation

-Frequency not reported: Dyspnea, wheezing