Natesto nasal gel 5.5 mg/.122g
testosterone · GEL, METERED · Acerus Pharmaceuticals Corporation
Natesto nasal gel is a gel, metered containing testosterone at 5.5 mg/.122g, taken nasal. Manufactured by Acerus Pharmaceuticals Corporation.
Key Facts
- Brand Name
- Natesto nasal gel
- Generic Name
- testosterone
- NDC Code (Product)
42667-5511- Manufacturer
- Acerus Pharmaceuticals Corporation
- Strength
- 5.5 mg/.122g
- Dosage Form
- GEL, METERED
- Route
- NASAL
- Marketing Status
- DEA Schedule
- Schedule III (Controlled)
- Application #
- NDA205488
- Drug Class
- Androgen [EPC]
- Marketing Start
- 05/08/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1. INDICATIONS AND USAGE Natesto is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Limitations of use: Safety and efficacy of Natesto in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established. Safety and efficacy of Natesto in males less than 18 years old have not been established [see Use in Specific Populations ( 8.4 )] . Natesto…
Dosage & Administration
2. DOSAGE AND ADMINISTRATION Prior to initiating Natesto, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range. Prior to initiating Natesto, confirm the diagnosis of hypogonadism by ensuring that serum testosterone has been measured in the morning on at least two separate days and that these concentrations are below the normal range ( 2 ). The recommended dose of Natesto is 11 mg of testosterone (2 pump actuations, one per nostril), applied intranasally three times daily. ( 2.1 ) Serum total testosterone concentrations should be checked periodically, starting as soon as one month after initiating treatment with Natesto. If total testosterone concentrations consistently exceed 1050 ng/dL, therapy with Natesto should be discontinued. If total testosterone concentrations are consistently below 300 ng/dL, an alternative treatment should be considered. ( 2.1 ) Not recommended for use with nasally administered drugs other than sympathomimetic decongestants (e.g., oxymetazoline). ( 2.3 , 7.4 , 12.3 ). 2.1. Dosing Th…
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 )
Drug Interactions
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 …
Adverse Reactions
6. ADVERSE REACTIONS Most common adverse reactions (incidence ≥3%) are: PSA increased, headache, rhinorrhea, epistaxis, nasal discomfort, nasopharyngitis, bronchitis, upper respiratory tract infection, sinusitis, and nasal scab. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Acerus Pharmaceuticals Corporation at 1-833-698-3786 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Natesto was evaluated in a multicenter, open-label, 90-day clinical study. Patients could continue treatment with Natesto in two, open-label extension periods for an additional 90 and 180 days, respectively. A total of 306 hypogonadal men with morning testosterone concentrations ≤ 300 ng/dL received Natesto. Of these, 78 received Natesto at a dose of 11 mg three times daily. 90-Day Clinical Study Among the 78 patients who received Natesto three times daily in the 90-day clinical study, the most common adverse re…
Frequently Asked Questions
What is Natesto nasal gel used for?
Natesto nasal gel contains testosterone. It is a gel, metered taken nasal. Consult your doctor for specific uses.
Is Natesto nasal gel a controlled substance?
Yes, Natesto nasal gel is classified as CIII under the DEA Controlled Substances Act.
What is the generic name for Natesto nasal gel?
The generic name for Natesto nasal gel is testosterone. There are 12 other brand versions of testosterone.
What is the NDC code for Natesto nasal gel 5.5 mg/.122g?
The NDC (National Drug Code) for Natesto nasal gel 5.5 mg/.122g is 42667-5511, listed by Acerus Pharmaceuticals Corporation.
Other Testosterone Brands
See all →- testosterone cypionate200 mg/mL76420-747
- Testosterone12.5 mg/10832-1121
- testosterone20.25 mg/1.25g16714-968
- AndroGel10 mg/g17139-501
- Depo-Testosterone200 mg/mL0009-0417
- Testosterone Cypionate200 mg/mL50090-4920
- Testosterone50 mg/5g64380-152
- testosterone cypionate200 mg/mL70700-289
- testosterone cypionate200 mg/mL76420-752
- TESTOSTERONE ENANTHATE200 mg/mL0143-9750
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)