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This section of the website is for UK healthcare professionals only. If you are not a healthcare professional, please click here.

About PROPECIA® (finasteride)

Prescribing Information

Helping patients with their hair journey

PROPECIA is a tablet indicated for the the treatment of men with male pattern hair loss (androgenic alopecia) in the UK that can prevent further hair loss and increase hair growth.1 PROPECIA is suitable for men who have begun to show signs of mild to moderate hair loss. Efficacy data supports the use of PROPECIA in men with continued treatment over a sustained period. More than five years of safety data is available. PROPECIA is not indicated for use in women or children and adolescents.

PROPECIA is proven to lower elevated dihydrotestosterone (DHT) levels, the primary cause of MPHL. 1,2

PROPECIA inhibits the enzyme type II 5 alpha-reductase, blocking the conversion of testosterone to DHT, thereby inhibiting the process responsible for miniaturisation of the scalp hair follicles, which can lead to reversal of the balding process.1,2

Please refer to the PROPECIA Summary of Product Characteristics for full information on clinical uses, contraindications, dosing and administration.

PROPECIA and Male Pattern Hair Loss

PROPECIA can be an effective treatment for early stages of male pattern hair loss (MPHL).3 PROPECIA begins working to lower dihydrotestosterone (DHT) levels from the first day of treatment and patients may start to see new hair growth after six months.

Slow, Grow, Know

Results with PROPECIA are not usually visible immediately and three to six months of daily treatment may be required before effects of treatment are noticed.1,3

In a 5-year-long clinical study, 9 of 10 men treated with PROPECIA had visible results, including no further hair loss and regrowth of hair, based on global photographic assessment by a dermatologist panel.4 After five years using finasteride 1 mg: 4  

5% (n=14/279) of men showed a great increase in their hair growth
21% (n=59/279) of men showed a moderate increase in their hair growth
22% (n=61/279) of men showed a slight increase in their hair growth
42% (n=117/279) of men showed no change in their hair growth
10% (n=28/279) of men had no visible result – that is to say, hair loss had continued

However, men do not need to wait five years to know whether PROPECIA is going to work for them.3

Efficacy and duration of treatment should continuously be assessed. Generally, three to six months of once daily treatment are required before evidence of stabilisation of hair loss can be expected. Continuous use is recommended to sustain benefit. If treatment is stopped, the beneficial effects begin to reverse by six months and return to baseline by nine to 12 months.1

PROPECIA Selected Safety Information

Contraindications

Use in women due to the risk in pregnancy. Hypersensitivity to the active substance or any of the excipients. Use in men who are taking finasteride 5 mg or any other 5a-reductase inhibitor. 'PROPECIA' is not indicated for use in women or children and adolescents.

Special warnings and precautions for use

Effects on Prostate Specific Antigen (PSA) with potential to decrease PSA level. Doubling the PSA level in men taking 'PROPECIA' should be considered before evaluating this test result. Breast cancer has been reported in men taking finasteride 1 mg during the post-marketing period. Physicians should instruct patients to promptly report changes in their breast tissue such as lumps, pain, gynaecomastia or nipple discharge. Mood alterations including depressed mood, depression and, less frequently, suicidal ideation have been reported in patients treated with finasteride 1 mg. Patients should be monitored for psychiatric symptoms and if these occur, treatment with finasteride should be discontinued and the patient advised to seek medical advice. Long-term data on fertility in humans are lacking, and specific studies in subfertile men have not been conducted; refer to the Summary of Product Characteristics for further information.

Table 1 – frequency of adverse events

Immune system disorders Not known: Hypersensitivity reactions, including rash, pruritus, urticaria and swelling of the lips and face
Cardiac disorder Not known: Palpitation
Psychiatric disorder Uncommon*: Decreased libido
Uncommon: Depressed mood
Hepatobiliary disorders Not known: Increased hepatic enzymes
Reproductive system and breast disorders Uncommon*: Erectile dysfunction, ejaculation disorder (including decreased volume of ejaculate) Not known: Breast tenderness and enlargement, testicular pain, infertility**.

*Incidences presented as difference from placebo in clinical studies at Month 12
This adverse reaction was identified through post-marketing surveillance but the incidence in randomised controlled Phase III clinical trials (Protocols 087, 089 and 092) was not different between finasteride and placebo.
**see Section 4.4 PROPECIA Summary of Product Characteristics.

Refer to PROPECIA Summary of Product Characteristics1 for more information

FAQs1

The following are questions your patient may ask you:

Q. I already have a receding hairline, will PROPECIA work for me?

A. This medication is suitable for men who have begun to show signs of mild to moderate male pattern hair loss, such as a receding hair line, or a thinning of the hair on the scalp.

Q. Will PROPECIA cure my hair loss completely?

A. No, the medication will not cure your hair loss, however, clinical trials have shown that at 24 months this medication improved hair growth, based on hair count, in two-thirds (66%) of men, compared with just 7% of those taking no drug. After 5 years, nine out of 10 (90%) of men taking this medication had visible results (re-growth or no further hair loss). Nearly half (48%) were rated as improved compared with 6% of men who took no drug. It will take three to six months before you can expect to see evidence of stabilisation of hair loss, so stay on the treatment to give yourself the best chance of success. You will need to keep taking your treatment to see the benefit, otherwise you may lose the hair you have gained so far within nine to twelve months.4

Q. Can PROPECIA be used in women too?

A. No, this medication is not indicated for use by women.

Q. I’ve heard this treatment can affect my sex drive, should I be worried?

A. In clinical studies, some men (Uncommon ≥1/1,000, <1/100) experience less desire to have sex and/or difficulty in achieving an erection which may continue after stopping the medication. A similar number (Uncommon ≥1/1,000, <1/100) may have a decrease in the amount of semen released during sex (this does not appear to interfere with normal sexual function).

Q. Can I take this medication if I am trying to have children?

A. Although Animal studies did not show relevant negative effects on fertility, spontaneous reports of infertility and/or poor seminal quality were received post marketing. A small amount of PROPECIA, (less than 0.001%) has been detected in semen of men taking the treatment. Animal studies have shown that this amount is unlikely to be a risk to the developing baby. On balance when reviewing this information we do not recommend use of this medication if you are planning to father a child.

References

  1. PROPECIA Summary of Product Characteristics.
  2. Kaufman KD. Androgen metabolism as it affects hair growth in androgenetic alopecia. Dermatol Clin. 1996; 14(4): 697–711.
  3. Kaufman KD, Olsen EA, Whiting D, et al. Finasteride Male Pattern Hair Loss Study Group. Finasteride in the treatment of men with androgenetic alopecia. J Am Acad Dermatol. 1998; 39(4): 578–589.
  4. Kaufman KD; for the finasteride Male Pattern Hair Loss Study Group. Long term (5-year) multinational experience with finasteride 1 mg in the treatment of men with androgenetic alopecia. Eur J Dermatol. 2002; 12(1): 38–49.

Supporting documentation

Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

GB-PRO-00031 | Date of Preparation: September 2020