Drugs List

Therapeutic Indications

Uses

Luteal support after oocyte retrieval during assisted reproduction

Administration

To be given by subcutaneous or intramuscular injection.

Contraindications

Children under 18 years
Breast cancer
Breastfeeding
Cerebrovascular disorder
Ectopic pregnancy
Female genital cancer
History during pregnancy of pemphigoid gestationis
History of cholestatic jaundice during pregnancy
History of pruritus during pregnancy
History of thromboembolic disorder
Ischaemic heart disease
Missed abortion
Porphyria
Severe hepatic impairment
Thrombophlebitis
Undiagnosed gynaecological haemorrhage
Venous thromboembolism

Precautions and Warnings

Patients over 65 years
Predisposition to thromboembolic disease
Tobacco smoking
Asthma
Atherosclerosis
Cardiac impairment
Diabetes mellitus
Epileptic disorder
History of severe depression
Migraine
Mild hepatic impairment
Renal impairment
Severe depression

Advise ability to drive/operate machinery may be affected by side effects
Exclude breast cancer before treatment
Treatment to be prescribed under the supervision of a specialist
Exclude other causes of infertility before commencing treatment
Monitor blood glucose closely in patients with diabetes mellitus
Monitor patients with a history of depression and/or suicide attempts
Investigate occurrence of visual disturbance or severe headache
Avoid abrupt withdrawal
Discontinue at first signs of thrombophlebitis or thromboembolism
Discontinue if arterial thromboembolism develops
Discontinue if cerebrovascular disorders occur
Discontinue if depression worsens or recurs
Discontinue if first occurrence or worsening of migraine/severe headache
Discontinue if first occurrence or worsening of visual disturbances
Discontinue if retinal thrombosis occurs
Advise patient not to take St John's wort concurrently

Pregnancy and Lactation

Pregnancy

Progesterone is considered safe for use during pregnancy.

Progesterone is indicated for luteal support as part of an Assisted Reproductive Technology (ART) treatment program in infertile women.

There is limited and inconclusive data on the risk of congenital anomalies, including genital abnormalities in male or female infants, following intrauterine exposure during pregnancy. The rates of congenital anomalies, spontaneous abortion and ectopic pregnancies observed during the clinical trial were comparable with the event rate described in the general population, although the total exposure is too low to allow conclusions to be drawn.

Lactation

Progesterone is contraindicated during breastfeeding.

The manufacturer states that progesterone is excreted in human milk and should not be used during breastfeeding.

LactMed suggests that because of the low levels of progesterone in breastmilk, even with the high-dose products, amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants.

Side Effects

Abdominal distension
Abdominal pain
Breast pain
Breast tenderness
Constipation
Dizziness
Fatigue
Feeling hot
Gastro-intestinal disturbances
Haematoma (injection site)
Headache
Induration (injection site)
Injection site reactions
Malaise
Mood changes
Nausea
Ovarian hyperstimulation syndrome (OHSS)
Pain
Pruritus
Rash
Somnolence
Uterine spasm
Vaginal discharge
Vaginal haemorrhage
Vomiting
Vulvovaginal discomfort
Vulvovaginal itching

Presentation

Solution for injection containing 25mg progesterone per 1.112ml.

Drugs List

Therapeutic Indications

Uses

Luteal support after oocyte retrieval during assisted reproduction

Dosage

Adults

Administration

To be given by subcutaneous or intramuscular injection.

Contraindications

Children under 18 years
Breast cancer
Breastfeeding
Cerebrovascular disorder
Ectopic pregnancy
Female genital cancer
History during pregnancy of pemphigoid gestationis
History of cholestatic jaundice during pregnancy
History of pruritus during pregnancy
History of thromboembolic disorder
Ischaemic heart disease
Missed abortion
Porphyria
Severe hepatic impairment
Thrombophlebitis
Undiagnosed gynaecological haemorrhage
Venous thromboembolism

Precautions and Warnings

Patients over 65 years
Predisposition to thromboembolic disease
Tobacco smoking
Asthma
Atherosclerosis
Cardiac impairment
Diabetes mellitus
Epileptic disorder
History of severe depression
Migraine
Mild hepatic impairment
Renal impairment
Severe depression

Advise ability to drive/operate machinery may be affected by side effects
Exclude breast cancer before treatment
Treatment to be prescribed under the supervision of a specialist
Exclude other causes of infertility before commencing treatment
Monitor blood glucose closely in patients with diabetes mellitus
Monitor patients with a history of depression and/or suicide attempts
Investigate occurrence of visual disturbance or severe headache
Avoid abrupt withdrawal
Discontinue at first signs of thrombophlebitis or thromboembolism
Discontinue if arterial thromboembolism develops
Discontinue if cerebrovascular disorders occur
Discontinue if depression worsens or recurs
Discontinue if first occurrence or worsening of migraine/severe headache
Discontinue if first occurrence or worsening of visual disturbances
Discontinue if retinal thrombosis occurs
Advise patient not to take St John's wort concurrently

Pregnancy and Lactation

Pregnancy

Progesterone is considered safe for use during pregnancy.

Progesterone is indicated for luteal support as part of an Assisted Reproductive Technology (ART) treatment program in infertile women.

There is limited and inconclusive data on the risk of congenital anomalies, including genital abnormalities in male or female infants, following intrauterine exposure during pregnancy. The rates of congenital anomalies, spontaneous abortion and ectopic pregnancies observed during the clinical trial were comparable with the event rate described in the general population, although the total exposure is too low to allow conclusions to be drawn.

Lactation

Progesterone is contraindicated during breastfeeding.

The manufacturer states that progesterone is excreted in human milk and should not be used during breastfeeding.

LactMed suggests that because of the low levels of progesterone in breastmilk, even with the high-dose products, amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants.

Side Effects

Abdominal distension
Abdominal pain
Breast pain
Breast tenderness
Constipation
Dizziness
Fatigue
Feeling hot
Gastro-intestinal disturbances
Haematoma (injection site)
Headache
Induration (injection site)
Injection site reactions
Malaise
Mood changes
Nausea
Ovarian hyperstimulation syndrome (OHSS)
Pain
Pruritus
Rash
Somnolence
Uterine spasm
Vaginal discharge
Vaginal haemorrhage
Vomiting
Vulvovaginal discomfort
Vulvovaginal itching

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: November 2018

Reference Sources

Summary of product characteristics: Lubion 25mg/1.112ml solution for injection. IBSA Farmaceutici Italia Srl. Revised March 2018.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).

Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Progesterone Last revised: 31 October 2018
Last accessed: 22 November 2018

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 November 2018