Drugs List

Administration

For topical application.

The cream should be rubbed in thoroughly. Eflornithine cream should be applied such that no visual residual product remains on the treated areas. The treatment area should not be cleansed for 4 hours following application in order to ensure maximal efficacy. Cosmetics and sunscreens may be applied to the treatment area but no sooner than 5 minutes after application. Contact with eyes and mucous membranes should be avoided. Hands should be washed thoroughly following application. Efficacy has only been demonstrated for areas of the face and under the chin, therefore application should be limited to these areas. Patients may need to continue with the use of a hair removal method (e.g. plucking or shaving) whilst using eflornithine cream. In such cases, eflornithine cream should be applied no sooner than 5 minutes after hair removal, as increased stinging or burning may occur.

Contraindications

Pregnancy ( see Pregnancy section )
Lactation ( see Lactation section )
Children under 12 years

Precautions and Warnings

Excessive facial hair growth in women may occur as a result of serious underlying disorders (e.g. polycystic ovary syndrome, androgen secreting neoplasm) or from the use of certain medicinal products. When prescribing eflornithine cream, these factors should be considered.

Renal impairment - (see Dosage, Renal Impairment)

Hepatic impairment - (see Dosage, Hepatic Impairment)

Contact with eyes and mucous membranes should be avoided.

The preparation contains cetostearyl alcohol and stearyl alcohol which may cause local skin reactions. The preparation also contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions, which may be delayed.

Should skin irritation or intolerance occur, treatment should be reduced to one application a day. If skin irritation continues, treatment should be discontinued.

Transient stinging or burning may occur if eflornithine cream is applied to abraded or broken skin.

Pregnancy and Lactation

Pregnancy

Eflornithine is contraindicated during pregnancy.

Animal studies in rats and rabbits, at high doses have shown reproductive toxicity, without evidence of teratogenicity, from the use of eflornithine.
19 pregnancies were recorded during trials with topical eflornithine. These exposures resulted in: 5 elective abortions, 4 miscarriage, 1 child with Down syndrome (mother aged 35 years) and 9 healthy infants. Women who are pregnant or planning pregnancy should use alternative means to manage facial hair.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Eflornithine is contraindicated during lactation.

It is not known if eflornithine is excreted in human breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Acne
Pseudofolliculitis barbae
Alopecia
Stinging
Burning sensation
Dry skin
Pruritus
Erythema
Tingling sensation
Irritation (localised)
Rash
Folliculitis
Ingrown hair
Oral oedema
Dermatitis
Papulovesicular rash
Bleeding skin
Herpes simplex
Eczema
Cheilitis
Furunculosis
Contact dermatitis
Hypopigmentation
Flushing
Numbness
Sore skin
Rosacea
Seborrhoeic dermatitis
Skin neoplasm
Maculopapular rash
Skin cysts
Vesiculo-bullous reactions
Skin disorder
Hirsutism
Skin tightness
Facial oedema
Hair growth abnormal
Changes in hair texture
Oral oedema

Drugs List

Dosage

Adults

Elderly

Children

Adolescents

Patients with Renal Impairment

Patients with Hepatic Impairment

Additional Dosage Information

Administration

For topical application.

The cream should be rubbed in thoroughly. Eflornithine cream should be applied such that no visual residual product remains on the treated areas. The treatment area should not be cleansed for 4 hours following application in order to ensure maximal efficacy. Cosmetics and sunscreens may be applied to the treatment area but no sooner than 5 minutes after application. Contact with eyes and mucous membranes should be avoided. Hands should be washed thoroughly following application. Efficacy has only been demonstrated for areas of the face and under the chin, therefore application should be limited to these areas. Patients may need to continue with the use of a hair removal method (e.g. plucking or shaving) whilst using eflornithine cream. In such cases, eflornithine cream should be applied no sooner than 5 minutes after hair removal, as increased stinging or burning may occur.

Contraindications

Pregnancy ( see Pregnancy section )
Lactation ( see Lactation section )
Children under 12 years

Precautions and Warnings

Excessive facial hair growth in women may occur as a result of serious underlying disorders (e.g. polycystic ovary syndrome, androgen secreting neoplasm) or from the use of certain medicinal products. When prescribing eflornithine cream, these factors should be considered.

Renal impairment - (see Dosage, Renal Impairment)

Hepatic impairment - (see Dosage, Hepatic Impairment)

Contact with eyes and mucous membranes should be avoided.

The preparation contains cetostearyl alcohol and stearyl alcohol which may cause local skin reactions. The preparation also contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions, which may be delayed.

Should skin irritation or intolerance occur, treatment should be reduced to one application a day. If skin irritation continues, treatment should be discontinued.

Transient stinging or burning may occur if eflornithine cream is applied to abraded or broken skin.

Pregnancy and Lactation

Pregnancy

Eflornithine is contraindicated during pregnancy.

Animal studies in rats and rabbits, at high doses have shown reproductive toxicity, without evidence of teratogenicity, from the use of eflornithine.
19 pregnancies were recorded during trials with topical eflornithine. These exposures resulted in: 5 elective abortions, 4 miscarriage, 1 child with Down syndrome (mother aged 35 years) and 9 healthy infants. Women who are pregnant or planning pregnancy should use alternative means to manage facial hair.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Eflornithine is contraindicated during lactation.

It is not known if eflornithine is excreted in human breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Counselling

Advise patients that continued use is necessary to maintain effect.

Should skin irritation or intolerance occur, treatment should be reduced to one application a day. If skin irritation continues, treatment should be discontinued and the treating physician should be consulted.

The cream should be rubbed in thoroughly.

Eflornithine cream should be applied such that no visual residual product remains on the treated areas. The treatment area should not be cleansed for 4 hours following application in order to ensure maximal efficacy.

Cosmetics and sunscreens may be applied to the treatment area but no sooner than 5 minutes after application.

Advise patients to avoid contact with eyes and mucous membranes.

Instruct patients to wash their hands after application of the cream.

Efficacy has only been demonstrated for areas of the face and under the chin, therefore application should be limited to these areas.

Patients may need to continue with the use of a hair removal method (e.g. plucking or shaving) whilst using eflornithine cream. In such cases, eflornithine cream should be applied no sooner than 5 minutes after hair removal, as increased stinging or burning may occur.

Side Effects

Acne
Pseudofolliculitis barbae
Alopecia
Stinging
Burning sensation
Dry skin
Pruritus
Erythema
Tingling sensation
Irritation (localised)
Rash
Folliculitis
Ingrown hair
Oral oedema
Dermatitis
Papulovesicular rash
Bleeding skin
Herpes simplex
Eczema
Cheilitis
Furunculosis
Contact dermatitis
Hypopigmentation
Flushing
Numbness
Sore skin
Rosacea
Seborrhoeic dermatitis
Skin neoplasm
Maculopapular rash
Skin cysts
Vesiculo-bullous reactions
Skin disorder
Hirsutism
Skin tightness
Facial oedema
Hair growth abnormal
Changes in hair texture
Oral oedema

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: October 2011

Reference Sources

British National Formulary, 62nd Edition (2011) Pharmaceutical Press, London.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Summary of Product Characteristics: Vaniqa 11.5% cream. Almirall Ltd. Revised March 2011.