Testosterone (nasal)
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Handling and access
NIOSH hazardous drug
Table 2NIOSH lists testosterone as a hazardous drug. AHFS class: 68:08 androgens.
- Meets the NIOSH definition of a hazardous drug (carcinogenicity, developmental or reproductive toxicity, organ toxicity at low doses, or genotoxicity) without MSHI or a Group 1 or 2A carcinogen classification.
- Only a developmental and/or reproductive hazard: precautions matter most for workers who are pregnant, breastfeeding, or trying to conceive.
Handle with the precautions your facility uses for hazardous drugs (USP <800>). NIOSH's Managing Hazardous Drug Exposures lists controls by drug form and activity.
Androgen
Dosing in kidney impairment
Potential for Adverse Effects on Spermatogenesis: Exogenous administration of androgens may lead to azoospermia Edema: Edema with or without congestive heart failure (CHF) may be a complication in patients with preexisting cardiac, renal, or hepatic disease. Sleep apnea: Sleep apnea may occur in those with risk factors.
If these occur, promptly discontinue Natesto while the cause is evaluated. 5.11 Edema Androgens, including Natesto, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required. 5.12 Gynecomastia Gynecomastia may develop and may persist in patients being treated with androgens, including Natesto, for hypogonadism .[see Adverse Reactions]. 5.13 Sleep Apnea The treatment of hypogonadal men with testosterone may potentiate sleep apnea in some patients, especially those with risk factors such as obesity and chronic lung disease. 5.14 Lipid Changes Changes in the serum lipid profile may occur.
Preparation and administration
Temporary Discontinuation of Use for Severe Rhinitis If the patient experiences an episode of severe rhinitis, temporarily discontinue Natesto therapy pending resolution of the severe rhinitis symptoms. If the severe rhinitis symptoms persist, an alternative testosterone replacement therapy is recommended.
Drug interactions
Check testosterone (nasal) against a medication listLabel text (5 paragraphs)
7. DRUG INTERACTIONS Androgens may decrease blood glucose and therefore may decrease insulin requirements in diabetic patients. ( 7.1 ) Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of International Normalized Ratio (INR) and prothrombin time is recommended in patients taking warfarin. ( 7.2 ) Use of testosterone with corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease. ( 7.3 )
7.1 Insulin Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of anti-diabetic medication.
7.2 Oral Anticoagulants Changes in anticoagulant activity may be seen with androgens, therefore more frequent monitoring of international normalized ration (INR) and prothrombin time is recommended in patients taking warfarin, especially at the initiation and termination of androgen therapy.
7.3 Corticosteroids The concurrent use of testosterone with corticosteroids may result in increased fluid retention and requires monitoring particularly in patients with cardiac, renal, or hepatic disease.
7.4 Oxymetazoline A 2.6% decrease in mean AUC(0-24) and 3.6% decrease in mean C max of total testosterone was observed in males with symptomatic seasonal rhinitis when treated with oxymetazoline 30 minutes prior to Natesto compared to when left untreated. Oxymetazoline does not impact the absorption of testosterone when concomitantly administered with Natesto [see Clinical Pharmacology ( 12.3 )] . Drug interaction potential with other nasally administered drugs other than oxymetazoline has not been studied.
Contraindications
4. CONTRAINDICATIONS Natesto is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [ see Warnings and Precaution ( 5.5 )]. Natesto is contraindicated in women who are or who may become pregnant, or who are breast- feeding. 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 [ see Warnings and Precautions ( 5.8 ) and Use in Specific Populations ( 8.1 , 8.3 )].
Men with carcinoma of the breast or known or suspected prostate cancer ( 4 , 5.5 ) Pregnant or breast-feeding women. Testosterone may cause fetal harm ( 4 , 8.1 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for testosterone (nasal). Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1. Pregnancy Pregnancy Category X — Natesto is contraindicated during pregnancy or in women who may become pregnant. Testosterone is teratogenic and may cause fetal harm. Exposure of a fetus to androgens may result in varying degrees of virilization. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
Lactation
8.3. Nursing Mothers Although it is not known how much testosterone transfers into human milk, Natesto is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants.
Breastfeeding (LactMed)
Limited data indicate that a low-dose (100 mg) subcutaneous testosterone pellet given to a nursing mother appears not to increase milk testosterone levels markedly. Subcutaneous testosterone cypionate does increase milk testosterone levels. However, testosterone has low oral bioavailability because of extensive first-pass metabolism, so it appears to not increase serum testosterone levels in breastfed infants. Breastfed infants appear not to be adversely affected by maternal or transgender paternal testosterone therapy. High doses of testosterone can suppress lactation.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.