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

Applies to histrelin: subcutaneous implant.

Serious side effects of Vantas

Along with its needed effects, histrelin (the active ingredient contained in Vantas) 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 histrelin:

Rare

• Bloody urine
• decreased frequency or amount of urine
• increased thirst
• loss of appetite
• lower back or side pain
• nausea
• swelling of the face, fingers, or lower legs
• trouble breathing
• unusual tiredness or weakness
• vomiting
• weight gain

Incidence not known

• Bloating of the stomach
• blurred or double vision
• change in ability to see colors, especially blue or yellow
• dark urine
• discouragement
• dizziness
• eye pain
• feeling sad or empty
• irritability
• light-colored stools
• loss of interest or pleasure
• seizures
• severe headache
• stomach pain
• trouble concentrating
• trouble sleeping
• yellow eyes or skin

Other side effects of Vantas

Some side effects of histrelin 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

• Decrease in testicle size
• feeling of warmth
• local infection, irritation, pain, redness, or swelling on the skin where the implant was placed
• redness of the face, neck, arms, and upper chest
• sudden sweating

Less common

• Decreased interest in sexual intercourse
• difficulty having a bowel movement
• flushing or redness of the skin
• headache
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• swelling of the breast or breast soreness in both females and males
• unusually warm skin

Rare

• Bruising
• confusion
• constipation
• depression
• difficulty in moving
• dry mouth
• general feeling of discomfort or illness
• metallic taste
• muscle pain, stiffness, or weakness
• night sweats
• pain in the joints
• pale skin
• thirst
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

For Healthcare Professionals

Applies to histrelin: subcutaneous implant, subcutaneous kit.

Endocrine

Common (1% to 10%): Elevated blood glucose, gynecomastia

Uncommon (0.1% to 1%): Elevated blood lactate dehydrogenase, elevated blood testosterone

Rare (less than 0.1%): Benign pituitary tumor

Postmarketing reports: Pituitary apoplexy^[Ref]

Cardiovascular

Very common (10% or more): Hot flashes (66%)

Common (1% to 10%): Blushing

Uncommon (0.1% to 1%): Hematoma, peripheral edema

Rare (less than 0.1%): Palpitations, ventricular extrasystoles^[Ref]

Local

Implant/application site reactions includes discomfort, bruising, soreness, pain, tenderness, tingling, itching, erythema, inflammation, protrusion, and swelling.^[Ref]

Very common (10% or more): Implant/application site reaction (51%)

Common (1% to 10%): Implant/application site injury, keloid scar, scar, suture-related complication, post procedural pain

Postmarketing reports: Implant breakage^[Ref]

Other

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

Uncommon (0.1% to 1%): Sexual dysfunction, breast pain, breast tenderness, pain (exacerbated and non specific), swelling, feeling cold, bruising, malaise

Rare (less than 0.1%): Wound infection, disease progression^[Ref]

Psychiatric

Common (1% to 10%): Mood changes, depression, decreased libido, insomnia

Uncommon (0.1% to 1%): Irritability^[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, pain in the extremities

Uncommon (0.1% to 1%): Back pain, muscle spasm, muscle infiltration, neck pain, bone pain, muscle twitching, myalgia^[Ref]

Dermatologic

Common (1% to 10%): Contusion, hypotrichosis, hypertrichosis

Uncommon (0.1% to 1%): Night sweats, pruritus, hyperhidrosis

Rare (less than 0.1%): Skin infection^[Ref]

Gastrointestinal

Common (1% to 10%): Constipation

Uncommon (0.1% to 1%): Abdominal discomfort, nausea^[Ref]

Genitourinary

Common (1% to 10%): Erectile dysfunction, testicular atrophy, pollakisuria, urinary retention

Uncommon (0.1% to 1%): Male genital pruritus, dysuria, hematuria, elevated prostatic acid phosphatase, ureteral stent occlusion, urinary frequency

Rare (less than 0.1%): Dysmenorrhea, menorrhagia, metrorrhagia^[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia^[Ref]

Hepatic

Common (1% to 10%): Hepatic disorder

Uncommon (0.1% to 1%): Elevated aspartate aminotransferase

Postmarketing reports: Drug-induced liver injury^[Ref]

Immunologic

Rare (less than 0.1%): Influenza-like illness^[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache

Uncommon (0.1% to 1%): Tremor, lethargy

Rare (less than 0.1%): Migraine

Postmarketing reports: Seizures/convulsions^[Ref]

Renal

Common (1% to 10%): Impaired renal function

Uncommon (0.1% to 1%): Renal failure, nephrolithiasis, decreased creatinine clearance^[Ref]

Respiratory

Common (1% to 10%): Exertional dyspnea

Rare (less than 0.1%): Epistaxis^[Ref]