Dienogest oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of dienogest.
Drugs List
Therapeutic Indications
Uses
Treatment of endometriosis
Treatment of endometriosis post menarche
Dosage
Adults
One tablet to be taken daily at the same time each day. Tablet taking is continuous without regard to vaginal bleeding.
Dienogest can be started on any day of the menstrual cycle.
Each subsequent pack is to be started the day after the last tablet of the previous pack.
There is no experience in treatment with dienogest after 15 months in patients with endometriosis.
Children
Dienogest is not indicated in children prior to menarche.
Additional Dosage Information
Missed tablets
If the patient misses one or more tablets, a tablet should be taken immediately and continue the next dose on the next day at the usual time.
If vomiting or diarrhoea occurs within 3 to 4 hours of taking a tablet, another tablet should be taken immediately and continue the next dose on the next day at the usual time.
Contraindications
Abnormal liver function test
Breastfeeding
Cardiovascular disorder
Diabetes mellitus with vascular involvement
Hepatic neoplasm
History of hepatic neoplasm
History of severe arterial disorder
Hormone dependent neoplasm
Pregnancy
Severe arterial disorder
Severe hepatic disorder
Undiagnosed uterine bleeding
Venous thromboembolism
Precautions and Warnings
Children under 18 years
History of ectopic pregnancy
Predisposition to thromboembolic disease
Prolonged immobilisation
Recent surgery
Recent trauma
Risk of uterine bleeding
Anaemia
Diabetes mellitus
Galactosaemia
Glucose-galactose malabsorption syndrome
History of chloasma
History of cholestatic jaundice during pregnancy
History of severe depression
Hypertension
Lactose intolerance
Post partum
Severe depression
Uterine bleeding
May decrease glucose tolerance in patients with diabetes mellitus
Assess family medical history prior to commencing treatment
Discontinue hormonal contraception before treatment initiation
Exclude oestrogen dependent neoplasm before treatment
Some formulations contain lactose
Measure bone density in at risk patients prior to therapy
Perform a complete physical and gynaecological examination before therapy
Abnormal and/or irregular bleeding should be investigated
If intra-abdominal haemorrhage consider liver tumour
If pregnancy occurs possibility of ectopic pregnancy should be considered
If upper abdominal complaints/liver enlargement consider liver tumour
May induce insulin resistance
Monitor patient for signs and symptoms of depression
Advise patient of thromboembolic symptoms and to report them if they occur
Advise patient to report any new or worsening depression/suicidal ideation
Vomiting or severe diarrhoea may impair efficacy
May affect results of some laboratory tests
Discontinue prior to surgery: increased risk of thrombosis
Advise patient to seek advice at first indications of pregnancy
Discontinue if cholestatic jaundice occurs
Discontinue if depression worsens or recurs
Discontinue if hypertension develops
Discontinue if thromboembolism occurs
Advise patient not to take St John's wort concurrently
Female: Not for contraception.Use non-hormonal contraception, if required
Changes in menstrual bleeding patterns should be expected
Women with a history of chloasma should avoid exposure to sun/UV light
For long term immobilisation, discontinuing the use of dienogest is advisable. For elective surgery, discontinuation of dienogest should be at least four weeks in advance. Restarting treatment after two weeks of complete remobilisation.
Serious uterine bleeding
Uterine bleeding may be aggravated when taking dienogest, for example, in women with adenomyosis uteri or uterine leiomyomata. Heavy, continuous bleeding may lead to severe anaemia in some case. Discontinuation of dienogest should be considered in the event of anaemia.
Cholestatic jaundice and/or pruritus
Discontinue dienogest upon recurrence of cholestatic jaundice and/or pruritus, which occurred first during pregnancy or previous use of sex steroids.
Persistent ovarian follicles
Persistent ovarian follicles may occur during treatment with dienogest. Most follicles are asymptomatic, however, some follicles may be accompanied by pelvic pain.
Osteoporosis
Use of dienogest in children aged 12 to 18 years old over a treatment period of 12 months was associated with decreased bone mineral density. Patients who are at an increased risk of osteoporosis should have a risk-benefit assessment performed before starting dienogest.
Pregnancy and Lactation
Pregnancy
Dienogest is contraindicated during pregnancy.
Manufacturer advises there is no need to treat endometriosis during pregnancy. There is no indication in animal studies that dienogest has direct or indirect harmful effects with respect to reproductive toxicity.
Lactation
Dienogest is contraindicated during breastfeeding.
Manufacturer advises that a decision on whether to discontinue breastfeeding or to abstain from dienogest treatment should be made. This should take into account the benefit of breastfeeding for the child and the benefit of treatment for the mother. Animal data reports dienogest is excreted in breast milk however presence in human breast milk is unknown.
Side Effects
"Spotting" bleeding
Abdominal discomfort
Abdominal distension
Abdominal pain
Acne
Alopecia
Alteration of autonomic nervous system
Altered sensation in extremities
Amenorrhoea
Anaemia
Anxiety
Asthenia
Attention disturbances
Back pain
Bone pain
Breast changes
Breast discomfort
Breast mass
Changes in mood
Circulatory disturbances
Constipation
Decrease in bone mineral density
Depressed mood
Depression
Dermatitis
Diarrhoea
Dry eyes
Dry skin
Dyspnoea
Fibrocystic breast changes
Flatulence
Gastro-intestinal symptoms
Gingivitis
Hair growth abnormal
Headache
Hirsutism
Hot flushes
Hyperhidrosis
Hypotension
Increased appetite
Irregular uterine bleeding
Irritability
Loss of libido
Menstrual disturbances
Migraine
Muscle spasm
Nausea
Nervousness
Oedema
Onychoclasis
Ovarian cysts
Painful extremities
Palpitations
Pelvic pain
Pruritus
Seborrhoeic dermatitis
Skin photosensitivity
Skin pigmentation changes
Sleep disorders
Tinnitus
Urinary tract infections
Uterine bleeding
Vaginal bleeding
Vaginal candidiasis
Vaginal discharge
Vaginal dryness
Vaginitis
Vomiting
Weight gain
Weight loss
Effects on Laboratory Tests
Progestogens may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function; plasma levels of carrier proteins; parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis.
These changes generally remain within normal laboratory ranges.
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: March 2020
Reference Sources
Summary of Product Characteristics: Dimetrum 2mg tablets. Besins healthcare (UK) Ltd. Revised October 2021.
Summary of Product Characteristics: Zalkya 2mg film-coated tablets. Stragen UK Ltd. Revised September 2019.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 16 September 2022
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.