| TAH Drug Code | EAND |
|---|---|
| Indications | Testosterone replacement therapy in male hypogonadal disorders. |
| Dosing | Adult and elders: 5 g (50mg testosterone) of gel once daily, best in the morning, Maximum dose 10g /day. |
| Hepatic Impairment | Dose adjustment not necessary |
| Renal Impairment | Dose adjustment not necessary |
| Contraindications | Prostatic or mammary carcinoma. |
| Adverse Effects | Acne, alopecia, application site reaction, asthenia, depression, emotional lability, gynecomastia, headache, hypertension, abnormal lab tests (e.g. elevated hemoglobin or hematocrit, hyperlipidemia, elevated triglycerides, hypokalemia, decreased HDL, elevated glucose, elevated creatinine, or elevated total bilirubin), libido decreased, nervousness, breast pain, prostate disorder, testis disorder. Dermatologic: Acne (up to 8% ) Endocrine metabolic: Gynecomastia (up to 3% ) Gastrointestinal: Oral irritation, Buccal system (9.2% ) Neurologic: Headache (up to 4% ) Reproductive: Large prostate (11.7% ) |
| Pregnancy | Contraindicated |
| Lactation | Contraindicated |
| More Info | UpToDate |
| TAH Drug Code | ENNG |
|---|---|
| Indications | Testosterone replacement therapy in adult males |
| Dosing | Recommended Dose and Dosage Adjustment The recommended starting dose of NATESTO (testosterone) is 11.0 mg of testosterone (1 actuation per nostril) administered intranasally twice daily for a total daily dose of 22.0 mg. To ensure proper dosing, serum total testosterone concentrations should be measured after initiation of therapy to ensure that the desired concentrations (300 to 1050 nanogram/dL) are achieved. The NATESTO dose can be adjusted at least 30 days after starting treatment based on the serum total testosterone concentrations from a single blood draw, taken 20 minutes to 2 hours after morning administration of NATESTO. If the total testosterone measurement is less than 300 nanogram/dL, the daily testosterone dose may be increased from 22.0 mg (twice daily administration) to 33.0 mg (thrice daily administration), as instructed by a physician. Serum total testosterone concentrations should be checked periodically. The following rules should be applied: 1. For patients on 22.0 mg (twice daily administration): If the measured serum total testosterone concentration from the single morning blood draw is less than 300 nanogram/dL, the NATESTO? Product Monograph Page 15 of 39 daily dose of NATESTO may be increased from 22.0 mg (twice daily administration) to 33.0 mg (thrice daily administration); 2. For patients on 33.0 mg (thrice daily administration): If the measured serum total testosterone concentration from the single morning blood draw is consistently less than 300 nanogram/dL, or if a desired clinical response is not achieved, NATESTO should be discontinued and an alternative treatment should be considered. If a post-dose morning total testosterone concentration consistently exceeds 1050 nanogram/dL, NATESTO should be discontinued. |
| Hepatic Impairment | Dose adjustment not necessary |
| Renal Impairment | Dose adjustment not necessary |
| Contraindications | Natesto is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precaution. Natesto is contraindicated in women who are or who may become pregnant, or who are breastfeeding. Natesto may cause fetal harm when administered to a pregnant woman. Natesto may cause serious adverse reactions in nursing infants. Exposure of a fetus or nursing infant to androgens may result in varying degrees of virilization. If a pregnant woman is exposed to Natesto, she should be apprised of the potential hazard to the fetus. |
| Adverse Effects | Common Dermatologic: Acne (Up to 8% ), Application site reaction (2% to 16.1% ), Scab of skin, Nasal (3.8% to 5.8% ) Endocrine metabolic: Gynecomastia (1% to 3% ) Gastrointestinal: Oral irritation (9.2% ) Neurologic: Headache (1% to 6% ) Reproductive: Large prostate (11.7% ), Raised prostate specific antigen (1% to 11.1% ) Respiratory: Bleeding from nose (3.8% to 6.5% ), Bronchitis (3.8% to 4.3% ), Discomfort, Nasal (3.8% to 5.9% ), Nasal discharge (3.8% to 7.8% ), Nasopharyngitis (3.8% to 8.7% ), Sense of smell altered (5.8% ), Sinusitis (3.8% ), Upper respiratory infection (3.8% to 4.3% ) Serious Cardiovascular: Death, Cardiovascular, Edema, Myocardial infarction Hematologic: Deep venous thrombosis, Venous thromboembolism Hepatic: Cholestatic jaundice syndrome, Liver carcinoma, Neoplasm of liver, Peliosis hepatis Neurologic: Cerebrovascular accident Reproductive: Benign prostatic hyperplasia (Up to 2% ), Prostate cancer (Up to 1.2% ) Respiratory: Pulmonary embolism |
| Pregnancy | Contraindicated |
| Lactation | Contraindicated |
| More Info | UpToDate |
| TAH Drug Code | INEB |
|---|---|
| Indications | Testosterone replacement therapy for primary or secondary male hypogonadism < 65 years. |
| Dosing | 1000 mg every 10-12 weeks. |
| Hepatic Impairment | Dose adjustment not necessary |
| Renal Impairment | Dose adjustment not necessary |
| Contraindications | Androgen-dependent carcinoma of the prostate or male mammary gland; hypercalcemia accompanying malignant tumors; past or present liver tumors. Women. |
| Adverse Effects | Diarrhea, leg pain, arthralgia, dizziness, increased sweating, headache, dyspnea, acne, breast pain, gynecomastia, pruritus, skin reactions, testicular pain, inj site pain, SC hematoma at inj site. Dermatologic: Acne (up to 8% ) Endocrine metabolic: Gynecomastia (up to 3% ) Gastrointestinal: Oral irritation, Buccal system (9.2% ) Neurologic: Headache (up to 4% ) Reproductive: Large prostate (11.7% ) |
| Pregnancy | Contraindicated |
| Lactation | Contraindicated |
| More Info | UpToDate |
| TAH Drug Code | ISUS |
|---|---|
| Indications | Testosterone replacement therapy in male hypogonadal disorders. Osteoporosis due to androgen deficiency. |
| Dosing | 1 mL every 3 weeks. Deep IM only. |
| Hepatic Impairment | Dose adjustment not necessary |
| Renal Impairment | Dose adjustment not necessary |
| Contraindications | Known or suspected prostatic or mammary carcinoma. |
| Adverse Effects | Priapism, signs of excessive sexual stimulation, oligospermia, decreased ejaculatory vol; fluid & salt retention. In prepubertal boys, precocious sexual development, increased frequency of erections, phallic enlargement, premature epiphyseal closure. Dermatologic: Acne (up to 8% ) Endocrine metabolic: Gynecomastia (up to 3% ) Gastrointestinal: Oral irritation, Buccal system (9.2% ) Neurologic: Headache (up to 4% ) Reproductive: Large prostate (11.7% ) |
| Pregnancy | Contraindicated |
| Lactation | Contraindicated |
| More Info | UpToDate |