Tapros Depot

Tapros Depot Adverse Reactions

leuprorelin

Manufacturer:

Takeda
Full Prescribing Info
Adverse Reactions
Clinically Significant Adverse Reactions: Since interstitial pneumonia, accompanied by fever, coughing, dyspnea, abnormal chest X-ray may occur (<0.1%), the patient's condition should be closely observed. If any abnormality is observed, appropriate measures eg, treatment with adrenal cortical hormones should be taken.
Since anaphylactoid symptoms may occur (<0.1%), careful inquiry should be made and close observation should be made after the administration of Tapros Depot. If any abnormality is observed, appropriate measures should be taken.
Hepatid dysfunction or jaundice, with increased AST (GOT), ALT (GPT) may occur (frequency unknown). Development or aggravation of diabetes may occur (frequency unknown). Therefore, close observation should be made and if any abnormality is observed, appropriate measures should be taken.
Pituitary apoplexy has been reported in patients with pituitary adenoma (frequency unknown). Therefore, if headache, vision impairment, visual field disorder are observed immediately after the first dose of Tapros Depot, appropriate measures eg, surgical treatment should be taken after conducting examination.
Prostatic Cancer: At the beginning of the treatment (see Warnings and Precautions); the starting treatment can be sometimes accompanies by some aggravations of clinical signs and symptoms (flare phenomenon): Bone pain, hematuria, urinary obstruction and weakness of the lower limbs or paresthesia has been reported. These manifestations of the symptoms are usually transitory disappearing within 1-2 weeks during the pursuit of treatment. However, the possibility of potential exacerbation of these symptoms during the 1st few weeks of treatment has to be taken into consideration in patients with neurological disorders or with urinary obstruction.
Hepatic (Close Observation Should be Made): ≥5%: Increased LDH; 0.1 to <5%: Jaundice or increased AST (GOT), ALT (GPT), γ-GTP or ALP.
Endocrine: ≥5%: Hot flushes, feeling of warmth; 0.1 to <5%: Headache, facial hot flushes, dizziness, decreased libido, erectile disturbance, gynecomastia, testicular atrophy or discomfort in the perineal region.
Musculoskeletal: 0.1 to <5%: Arthralgia, bone pain in the shoulder, low back or limbs or difficulty in walking; <0.1%: Muscle ache or decreased bone mass.
Dermatologic: 0.1 to <5%: Dermatitis or hair growth on the head.
Urinary: 0.1 to <5%: Pollakiuria, dysuria or increased blood urea nitrogen (BUN).
Cardiovascular: 0.1 to <5%: ECG abnormalities or increased cardiothoracic ratio.
Hematologic: 0.1 to <5%: Anemia or decreased platelet count.
Gastrointestinal: 0.1 to <5%: Nausea, vomiting, anorexia; <0.1%: Diarrhea.
Hypersensitivity: 0.1 to <5%: Rash of pruritus.
Administration Site: 0.1 to <5%: Reactions at the injection site eg, pain, induration and redness; <0.1%: Abscess.
Others: 0.1 to <5%: Edema, pressure sensation of chest, rigor, malaise, numbness of lips or limbs, increased weight, paresthesia, deafness, tinnitus, fever, increased total cholesterol, triglyceride or uric acid, hyperkalemia or increased blood sugar level; <0.1%: Weakness.
Endometriosis, Uterine Myoma (Fibroid), Central Precocious Puberty, Breast Cancer: Symptoms Resulting from Decreased Estrogen: ≥5%: Hot flushes, feeling of warmth, feeling of hot flushes, shoulder stiffness, headache, insomnia, dizziness or diaphoresis; 0.1 to <5%: Decreased libido, coldness, visual disturbance or emotional lability.
Female Reproductive: 0.1 to <5%: Metrorrhagia, vaginal dryness, coital pain, vaginitis, increased fluor, ovarian hyperstimulation syndrome, or pain, swelling or atrophy of the breast.
Musculoskeletal: ≥5%: Pains eg, arthralgia and bone pain; 0.1 to <5%: Joint stiffness, lumbar pain, muscle ache, muscular spasm, decreased bone mass, increased serum phosphorus or hypercalcemia.
Dermatologic: 0.1 to <5%: Acne, dry skin, alopecia, hypertrichosis or nail abnormality.
Psychoneurologic: 0.1 to <5%: Sleepiness, irritated feeling, hypomnesia, decreased attentiveness or paresthesia.
Hypersensitivity: 0.1 to <5%: Rash of pruritus.
Hepatic (Close Observation Should be Made): 0.1 to <5%: Increased AST (GOT), ALT (GPT), ALP, LDH, γ-GTP or bilirubin; <0.1%: Jaundice.
Gastrointestinal: 0.1 to <5%: Nausea, vomiting, anorexia, abdominal pain, feeling of enlarged abdomen, diarrhea, constipation, stomatitis or thirst.
Cardiovascular: 0.1 to <5%: Palpitation or increased blood pressure.
Hematologic: 0.1 to <5%: Increased red blood cell count, anemia, decreased white blood cell, decreased platelet count or prolonged partial thromboplastin time.
Urinary: 0.1 to <5%: Pollakiuria, dysuria or increased BUN.
Administration Site: 0.1 to <5%: Reactions at the injection site eg, pain, induration and redness; <0.1%: Abscess.
Others: 0.1 to <5%: Fatigue, malaise, weakness, numbness of lips or limbs, carpal tunnel syndrome, tinnitus, deafness, chest discomfort, edema, increased weight, pain of lower extremities, respiratory distress, fever, increased total function cholesterol, LDL-cholesterol or triglyceride, or hyperkalemia; <0.1%: Decreased, taste abnomiality or abnormal thyroid function.
It has been reported that the administration of leuprorelin acetate brought about cerebral infarction, venous thrombosis or pulmonary embolism.
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