How times a day do you take this medicine?
What is Fortesta?
Fortesta is used for the treatment of men whose bodies do not make enough natural Fortesta, a condition called hypogonadism. Fortesta is a male hormone responsible for the growth and development of the male sex organs and maintenance of secondary sex characteristics.
Fortesta is also used in women with breast cancer that has spread to other parts of the body (metastatic).
Fortesta is also used to stimulate delayed puberty in male teenagers.
This medicine is to be given only by or under the direct supervision of your doctor. The Fortesta® brand is only available under a restricted distribution program called the Fortesta® REMS program.
Fortesta is indicated for Fortesta replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous Fortesta.
- Primary hypogonadism (congenital or acquired): testicular failure due to 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 Fortesta 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 Fortesta serum concentrations but have gonadotropins in the normal or low range.
Fortesta should only be used in patients who require Fortesta replacement therapy and in whom the benefits of the product outweigh the serious risks of pulmonary oil microembolism and anaphylaxis.
Limitations of use:
- Safety and efficacy of Fortesta in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
- Safety and efficacy of Fortesta in males less than 18 years old have not been established.
How should I use Fortesta?
Use Fortesta as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Fortesta comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Fortesta refilled.
- Prime this product before the first use. To prime it, depress the pump 3 times and wash any product that is dispensed down the sink.
- Depress the pump once to fill the applicator cup. Holding the applicator upright, wipe Fortesta steadily up and down onto clean, dry skin in the armpit. If Fortesta drips or runs, it can be wiped back up with the applicator cup. Do NOT apply Fortesta to other parts of your body (eg, scrotum, penis, stomach, shoulders, upper arms). Do NOT apply it over open sores, wounds, or irritated skin.
- Do NOT use your fingers or hand to rub the medicine into the skin.
- You may need to alternate between armpits when applying Fortesta. Be sure you understand how to apply Fortesta. Contact your doctor or pharmacist if you have questions or concerns about how to apply Fortesta.
- Wash your hands with soap and water immediately after using Fortesta.
- Allow Fortesta to dry completely before dressing.
- After Fortesta has dried, cover the application site (eg, with a shirt) to prevent others from coming into contact with Fortesta. If direct skin-to-skin contact with another person is expected, wash the application site well with soap and water to remove the medicine.
- After using Fortesta, rinse the applicator with room temperature water and pat it dry with a tissue. Replace the applicator and cap on the bottle for storage.
- Do NOT get Fortesta in your eyes. If you do, rinse thoroughly with water. If eye irritation persists, contact your doctor.
- Apply Fortesta at the same time every morning after showering or bathing, unless your doctor tells you otherwise.
- If you are also using an antiperspirant or deodorant (stick or roll-on), apply it at least 2 minutes before you apply Fortesta.
- For best results, wait 2 hours after applying Fortesta before you wash the application site or swim.
- If you miss a dose of Fortesta, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Fortesta.
Uses of Fortesta in details
This medication is used by men who do not make enough of a natural substance called Fortesta (hypogonadism). Fortesta belongs to a class of drugs known as androgens. Fortesta helps the body to develop and maintain male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire.
This drug should not be used by women.
How to use Fortesta nasal
Read the Patient Information Leaflet if available from your pharmacist before you start using Fortesta and each time you get a refill. Follow the illustrated directions for the proper use of this medication. If you have any questions, ask your doctor or pharmacist.
Gently blow your nose before using this medication. Follow the instructions on how to properly prime the bottle if you are using it for the first time.
Use this medication in the nose as directed by your doctor, usually 3 times a day (6 to 8 hours apart). After applying the medication into both nostrils, gently squeeze your nostrils together and lightly massage. Do not apply this medication to other areas of your body. If another part of your body comes in contact with this medication, wash the area with warm water and soap.
Do not blow your nose or sniff for 1 hour after using this medication. Wipe the tip of the applicator with a clean, dry tissue after each use.
Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.
Since this drug can be absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.
Tell your doctor if your condition does not improve or if it worsens.
Each mL of 100 mg/mL solution also contains the following excipients: Benzyl benzoate 0.1 mL, cottonseed oil 736 mg and benzyl alcohol (as preservative) 9.45 mg.
Each mL of 200 mg/mL solution also contains the following excipients: Benzyl benzoate 0.2 mL, cottonseed oil 560 mg and benzyl alcohol (as preservative) 9.45 mg.
Fortesta cypionate is the oil-soluble 17(β)-cyclopentylpropionate ester of the androgenic hormone Fortesta. It is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane ether and soluble in vegetable oils.
Fortesta cypionate is androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3 and the molecular weight is 412.61.
Prior to initiating, Fortesta confirm the diagnosis of hypogonadism by ensuring that serum Fortesta concentrations have been measured in the morning on at least two separate days and that these serum Fortesta concentrations are below the normal range.
Dosing and Dose Adjustment
The recommended starting dose of Fortesta® is 50 mg of Fortesta (one tube) applied once daily (preferably in the morning) to clean, dry intact skin of the shoulders and/or upper arms.
To ensure proper dosing, serum Fortesta concentrations should be measured. Morning, pre-dose serum Fortesta concentrations should be measured approximately 14 days after initiation of therapy to ensure proper serum Fortesta concentrations are achieved. If the serum Fortesta concentration is below the normal range (300 ng/dL to 1,000 ng/dL), the daily Fortesta dose may be increased from 50 mg Fortesta (one tube) to 100 mg Fortesta (two tubes) once daily.
The maximum recommended dose of Fortesta is 100 mg once daily.
The application site and dose of Fortesta are not interchangeable with other topical Fortesta products.
Upon opening the tube the entire contents should be squeezed into the palm of the hand and immediately applied to the shoulders and/or upper arms (area of application should be limited to the area that will be covered by the patient’s short sleeve T-shirt. Do not apply Fortesta to the genitals or to the abdomen.
Application sites should be allowed to dry for a few minutes prior to dressing. Hands should be washed thoroughly with soap and water after Fortesta has been applied. Avoid fire, flame or smoking during the application of Fortesta until the Fortesta has dried.
In order to prevent transfer to another person, wear clothing to cover the application sites. If direct skin-to-skin contact with another person is anticipated, the application sites must be washed thoroughly with soap and water.
The patient should avoid swimming or showering or washing the administration site for a minimum of 2 hours after application.
Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to Fortesta from Fortesta-treated skin:
- Children and women should avoid contact with unwashed or unclothed application site(s) of men using Fortesta.
- Fortesta should only be applied to the upper arms and shoulders. The area of application should be limited to the area that will be covered by a short sleeve T-shirt.
- Patients should wash their hands with soap and water immediately after applying Fortesta.
- Patients should cover the application site(s) with clothing (e.g., a T-shirt) after the gel has dried.
- Prior to situations in which direct skin-to-skin contact is anticipated, patients should wash the application site(s) thoroughly with soap and water to remove any Fortesta residue.
- In the event that unwashed or unclothed skin to which Fortesta has been applied comes in direct contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible.
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.
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.
The concurrent use of Fortesta with corticosteroids may result in increased fluid retention and requires monitoring particularly in patients with cardiac, renal, or hepatic disease.
A 2.6% decrease in mean AUC(0-24) and 3.6% decrease in mean Cmax of total Fortesta was observed in males with symptomatic seasonal rhinitis when treated with oxymetazoline 30 minutes prior to Fortesta compared to when left untreated. Oxymetazoline does not impact the absorption of Fortesta when concomitantly administered with Fortesta. Drug interaction potential with other nasally administered drugs other than oxymetazoline has not been studied.
Drug Abuse And Dependence
Fortesta contains testosterone injection, a Schedule III controlled substance in the Controlled Substances Act.
Anabolic steroids, such as Fortesta, are abused. Abuse is often associated with adverse physical and psychological effects.
Although drug dependence is not documented in individuals using therapeutic doses of anabolic steroids for approved indications, dependence is observed in some individuals abusing high doses of anabolic steroids. In general, anabolic steroid dependence is characterized by any three of the following:
- Taking more drug than intended
- Continued drug use despite medical and social problems
- Significant time spent in obtaining adequate amounts of drug
- Desire for anabolic steroids when supplies of the drug are interrupted
- Difficulty in discontinuing use of the drug despite desires and attempts to do so
- Experience of withdrawal syndrome upon discontinuation of anabolic steroid use
Fortesta side effects
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug can not be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Twelve Week Clinical Trials in Hypogonadal Men
In the Phase 3, open-label study, 98 patients received Fortesta for up to 12 weeks. Adverse reactions to Fortesta reported by ≥ 1% of patients are listed in Table 1.
Table 1: Adverse Reactions Observed With the Use of Fortesta in ≥ 1% of Patients
|Adverse Reaction||Fortesta |
|Gum or Mouth Irritation||9.2%|
Gum irritation generally resolved in 1 to 8 days. Gum tenderness resolved in 1 to 14 days.
The following adverse reactions to Fortesta occurred in 1 patient each: acne, anxiety, breast enlargement, breast pain, buccal mucosal roughening, difficulty in micturition, fatigue, gingivitis, gum blister, gustatory sense diminished, hematocrit increased, lipids serum increased, liver function tests abnormal, nose edema, stinging of lips, and toothache.
There was one additional 12-week study in 12 patients. In this study, additional adverse reactions to Fortesta and reported by 1 patient each included emotional lability and hypertension.
Long-Term Extension Clinical Trials in Hypogonadal Men
In two extension trials, a total of 117 and 51 patients received Fortesta for at least 6 months and 1 year, respectively.
Of 117 patients treated for at least 6 months, adverse reactions reported by 1 patient each included: anxiety, buccal inflammation, depression, dry mouth, gum redness, hypertension, infection, medication error, nausea, pruritus, renal function abnormal, stomatitis, taste bitter, taste perversion and toothache. Polycythemia and increased serum prostate specific antigen (PSA) were reported in three and two patients, respectively.
In these two extension studies, a total of 48 patients received Fortesta for at least 2 years. In these patients, adverse reactions included: gingival recession, lip ulceration, stomatitis, rash, prostate cancer, increased PSA, abdominal pain, diarrhea, hypertension aggravated, headache, nervousness, polycythemia, taste perversion, aggressiveness, hyperlipidemia, peripheral edema, and anxiety.
Gum-related Adverse Events And Gum Examinations
In the open-label study, all reported gum-related adverse events were collected and gum examinations were conducted at Baseline and every month thereafter.
A total of 16 patients reported 19 gum-related adverse reactions. Of these, ten patients (10.2%) reported 12 reactions of mild intensity, four patients (4.1%) reported 5 reactions of moderate intensity, and two patients (2.0%) reported 2 reactions of severe intensity. Four patients (4.1%) discontinued treatment with Fortesta due to gum or mouth-related adverse reactions including two with severe gum irritation, one with mouth irritation, and one with “bad taste in mouth.” Gum irritation generally resolved in 1 to 8 days. Gum tenderness resolved in 1 to 14 days.
Monthly gum examinations were conducted to assess for gingivitis, gum edema, oral lesions, ulcerations or leukoplakia. No cases of ulceration or leukoplakia were observed. No new oral lesions were observed. The incidence of gingivitis and gum edema was not increased during treatment.
In the two extension trials, gum examinations were conducted every 3 months while on treatment. In one of these trials, no patient had a gum abnormality, and in the other trial, moderate gingivitis and mild gum edema were reported by 1 patient each.
In these two extension studies, patient-reported information on Fortesta gum adherence was collected every 3 months for 1 year. At each visit, 37% to 52% of patients reported problems with Fortesta adhering to the gum. Circumstances surrounding Fortesta detachment included eating, drinking and oral care. Hot foods and hot beverages were more likely to be associated with detachment than cold food and cold beverages.
The following adverse reactions have been identified during post approval use of Fortesta. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: dry mouth, gingival swelling, lip swelling, mouth ulceration, stomatitis, red blood cell increased, dysgeusia, venous thromboembolism, myocardial infarction, and stroke.
- Fortesta 1% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate.
- Fortesta 1% is contraindicated in women who are or may become pregnant, or who are breastfeeding. Fortesta 1% may cause fetal harm when administered to a pregnant woman. Fortesta 1% may cause serious adverse reactions in nursing infants. Exposure of a female fetus or nursing infant to androgens may result in varying degrees of virilization. Pregnant women or those who may become pregnant need to be aware of the potential for transfer of Fortesta from men treated with Fortesta 1%. If a pregnant woman is exposed to Fortesta 1%, she should be apprised of the potential hazard to the fetus.
Active ingredient matches for Fortesta:
Testosterone in United States.
|Unit description / dosage (Manufacturer)||Price, USD|
|Fortesta gel, metered 10 mg/.5g (Endo Pharmaceuticals Inc. (US))|
List of Fortesta substitutes (brand and generic names):
|Gel; Topical; Testosterone 2%|
|Fortigel 2% (France)|
|Intrinsa (France, Germany, Ireland, Italy, Latvia, Lithuania, Netherlands, Spain, Sweden, United Kingdom)|
|Patch; Topical; Testosterone 300 mcg / 24 h (Procter & Gamble)|
|Intrinsa Transdermal patch 300 micrograms/24hours (Procter & Gamble)|
|Itnogen (Belgium, Spain)|
|Itnogen 2% (Luxembourg)|
|Jenasteron (South Korea)|
|Livensa (Latvia, Lithuania)|
|Livensa Transdermal patch 300 micrograms/24hours (Procter & Gamble)|
|Gel; Topical; Testosterone 1%|
|Injectable; Injection; Testosterone 100 mg / ml|
|Malogen in Oil|
|Injectable; Injection; Testosterone Propionate 100 mg / ml|
|Malogen, Aquaspension Injection|
|Injectable; Injection; Testosterone Enanthate 200 mg / ml|
|Injectable; Injection; Testosterone Propionate 100 mg / ml|
|MENOLON INJECTION 1 vial / 1 ML injection each (Mac Millon Pharmaceuticals Pvt Ltd)||$ 3.00|
|MENOLON SOFT GELATIN CAPSULE 1 strip / 10 soft gelatin capsules each (Mac Millon Pharmaceuticals Pvt Ltd)||$ 2.60|
|Menolon NA Soft Gelatin Capsule (Mac Millon Pharmaceuticals Pvt Ltd)||$ 2.67|
|Natesto gel 5.5 mg/1 (Endo Pharmaceuticals (US))|
|Natesto gel 4.5 % (Acerus Pharmaceuticals Srl (Canada))|
|Natesto Nasal Gel|
|Nebido (Antigua & Barbuda, Argentina, Aruba, Austria, Bahamas, Barbados, Belgium, Bermuda, Brazil, Bulgaria, Cayman Islands, Chile, Colombia, Costa Rica, Croatia (Hrvatska), Czech Republic, Denmark, Ecuador, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Grenada, Guatemala, Guyana, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Jamaica, Latvia, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Nicaragua, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saint Lucia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Suriname, Sweden, Switzerland, Taiwan, Thailand, Trinidad & Tobago, Turkey, United Kingdom)|
|Injectable; Injection; Testosterone Undecanoate 250 mg / ml (Bayer)|
|Nebido 1000 mg/4 mL x 1's (Bayer)||$ 196.57|
|Nebido 250 mg/1 mL x 4 mL (Bayer)||$ 200.07|
|Nebido / amp 250 mg/1 mL x 4 mL x 1's (Bayer)|
- DailyMed. "TESTOSTERONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "testosterone". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "testosterone". http://www.drugbank.ca/drugs/DB00624 (accessed September 17, 2018).
ReviewsThe results of a survey conducted on ndrugs.com for Fortesta are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Fortesta. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Consumer reported usefulNo survey data has been collected yet
Consumer reported price estimatesNo survey data has been collected yet
Consumer reported time for resultsNo survey data has been collected yet
Consumer reported ageNo survey data has been collected yet
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Information checked by Dr. Sachin Kumar, MD Pharmacology