Tapros 3M

Tapros 3M Adverse Reactions

leuprorelin

Manufacturer:

Takeda
Full Prescribing Info
Adverse Reactions
Clinically Significant Adverse Reaction: Since interstitial pneumonia, accompanied by fever, coughing, dyspnea, abnormal chest X-ray, etc 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 3M. If any abnormality is observed, appropriate measures should be taken.
Hepatic dysfunction or jaundice, with increased AST (GOT), ALT (GPT) etc may occur (frequency unknown). Therefore, close observation should be made, and if any abnormality is observed, appropriate measures should be taken.
Development or aggravation of diabetes may occur (frequency unknown). 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, etc are observed immediately after the 1st dose of Tapros 3M, appropriate measures eg, surgical treatment, should be taken after conducting examination.
Prostatic Cancer: At the Beginning of Treatment (see Warnings and Precautions): The start of treatment can be sometimes accompanied by some increase of clinical signs and symptoms (flare phenomenon): Bone pain, hematuria, urinary obstruction and weakness of the lower limbs/paresthesia has been reported.
These manifestations are usually transitory, disappearing within 1-2 weeks during the pursuit of the treatment. However, the possibility of potential exacerbations 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, warmth feeling; 0.1 to <5%: Headache, facial hot flushes, dizziness, diaphoresis, decreases libido, erectile disturbance, gynecomastia, testicular atrophy or discomfort in the perineal region.
Musculoskeletal: 0.1 to <5%: Arthralgia, bone pain, 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%: Poliakiuria, hematuria 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 or anorexia; <0.1%: Diarrhea.
Hypersensitivity: 0.1 to <5%: Rash of pruritus
Administration Site (Close Observation should be Made): 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 and 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: 0.1to <5%: Pollakiuria, dysuria or increased BUN.
Administration Site (Close Observation should be Made): 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 weight, 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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