Estradiol valerate and (estradiol valerate with dienogest) oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Tablets containing estradiol valerate and estradiol valerate with dienogest
Drugs List
Therapeutic Indications
Uses
Contraception - oral
Menorrhagia where oral contraception is also desired
Dosage
Adults
One tablet is taken daily for 28 consecutive days at the same time each day. Tablet taking is continuous.
Patients must take the tablets in the order directed on the packaging.
Each subsequent pack is to be started the day after the last tablet of the previous pack.
Starting therapy
No preceding hormonal contraceptive use (in the past month)
Tablet taking is to start on day 1 of the patient's menstrual cycle (i.e. on the first day of menstrual bleeding).
Changing from an oral combined hormonal contraceptive, vaginal ring or transdermal patch
Tablet taking is to start on the day after the last active tablet or on the day of removal of the previous hormonal contraceptive.
Changing from a progestogen-only method (minipill, implant or injection) or from a progestogen-releasing intrauterine system (IUS)
Patients taking the minipill may switch therapy on any day of the cycle. Patients using an IUS or implant should start treatment on the day of the removal of the previous contraceptive device. Patients receiving progestogen injection should start therapy on the day in which the next injection would be due. Additional contraceptive precautions should be taken for the first 9 days.
Following first-trimester abortion
Patient may start immediately. When doing so, no additional contraceptive methods are required.
Following delivery (not breastfeeding) or second-trimester abortion
Patient should be advised to begin therapy between days 21 and 28 following delivery or abortion. If therapy is started later, additional barrier contraceptive will be required for the first 9 days of therapy. If intercourse has already occurred, pregnancy should be excluded before initiating therapy.
Additional Dosage Information
If vomiting occurs within 3 to 4 hours of taking an active tablet, the next tablet should be taken as soon as possible. This tablet should be taken within 12 hours of the usual time. Where more than 12 hours have elapsed, the advice concerning missed tablets below should be followed.
Missed tablets
If the patient is less than 12 hours late, the tablet should be taken and no additional contraceptive protection will be required. Tablet taking may continue as normal.
If the patient is more than 12 hours late, contraceptive efficacy may be reduced and the patient should follow the following advice:
Tablet missed between days 1 to 17
Take missed tablet immediately and the following tablet as normal, even if this means taking two tablets during the same day.
Continue with tablet taking in the normal way, use additional contraception for the next 9 days.
Tablet missed between days 18 to 24
Discard current pack and immediately start with the first pill of the next pack.
Continue this pack as normal, use additional contraception for the next 9 days.
Tablet missed between days 25 to 26
Take missed tablet immediately and the following tablet as usual (even if this means taking two tablets on the same day).
Continue with tablet taking in the normal way, no additional contraception required.
Tablet missed between days 27 to 28 (inactive tablets)
Discard missed tablet and continue with tablet taking in the normal way.
No additional contraception required.
No more than two tablets are to be taken on a given day.
If the patient has forgotten to start a new pack or has missed a tablet during days 3 to 9 of the pack, she may be pregnant if she has had intercourse in the previous 7 days. Risk of pregnancy increases between tablets 3 to 24 and with increased number of missed tablets. If the patient misses tablets and has no withdrawal bleed at the end of the pack the possibility of pregnancy should be considered. In all these cases, pregnancy should be excluded before continuing therapy.
Contraindications
Children under 18 years
Major surgery with prolonged post-operative immobilisation
Predisposition to thromboembolic disease
Abnormal liver function test
Angina
Atherogenic lipid profile
Breastfeeding - until weaning or 6 months post partum
Cerebrovascular disorder
Diabetes mellitus with vascular involvement
Focal migraine
Galactosaemia
Hepatic neoplasm
History of hepatic neoplasm
History of myocardial infarction
History of thromboembolic disorder
Myocardial infarction
Oestrogen dependent neoplasm
Porphyria
Pregnancy
Severe dyslipoproteinaemia
Severe hepatic impairment
Severe hypertension
Thrombosis
Undiagnosed gynaecological haemorrhage
Precautions and Warnings
Body mass index above 30kg per square metre
Family history of thromboembolic disorder
Females over 35 years
Major surgery
Severe trauma
Tobacco smoking
Atrial fibrillation
Cardiac valvulopathy
Chronic inflammatory bowel disease
Coagulopathy
Depression
Diabetes mellitus
Dyslipoproteinaemia
Epileptic disorder
Familial hypertriglyceridaemia
Glucose-galactose malabsorption syndrome
Haemolytic uraemic syndrome
History of angioedema
History of chloasma
History of cholelithiasis
History of cholestatic jaundice during pregnancy
History of herpes gestationis
History of migraine
History of pruritus during pregnancy
Hyperlipidaemia
Hypertension
Lactose intolerance
Malignant neoplasm
Non focal aura migraine
Otosclerosis
Pancreatitis
Renal impairment
Sickle cell disease
Sydenham's chorea
Systemic lupus erythematosus
Assess family medical history prior to commencing treatment
Exclude oestrogen dependent neoplasm before treatment
Contains lactose
Resume use only after 2wks full ambulation from surgery/immobilisation
Do breast & pelvic exam. before & during treatment if clinically indicated
Exclude pregnancy prior to initiation of treatment
If upper abdominal complaints/liver enlargement consider liver tumour
May induce insulin resistance
Monitor blood glucose closely in patients with diabetes mellitus
Advise patient of thromboembolic symptoms and to report them if they occur
Consider discontinuing treatment if hepatotoxicity occurs
Increased risk of VTE during travel involving >5hr immobilisation
Irregular vaginal bleeding may occur
May affect results of some laboratory tests
Discontinue 4 - 6 weeks before major surgery
Discontinue if cholestatic jaundice occurs
Discontinue if epilepsy is exacerbated
Discontinue if first occurrence or worsening of migraine/severe headache
Discontinue if headache assoc with weakness/numbness one side/part occurs
Discontinue if headache associated with sudden dysphasia or vertigo occurs
Discontinue if headache associated with syncope or collapse occurs
Discontinue if headache with sudden partial/complete vision loss occurs
Discontinue if severe pain in the calf of one leg occurs
Discontinue if sudden breathlessness (or cough with blood stained sputum)
Discontinue if sudden pain in the chest occurs
Discontinue if suspicion of thrombosis/infarction
Interrupt therapy if severe hypertension requiring medical treatment occurs
Advise patient grapefruit products may increase plasma level
Advise patient concurrent St John's wort may reduce contraceptive effect
Missed dose, severe GI disturbances and vomiting may impair efficacy
Advise patient to read the leaflet in the pack
All contraceptive pills slightly increase the risk of breast cancer
Treatment does not protect against risk of sexually transmitted disease
Women with a history of chloasma should avoid exposure to sun/UV light
Assessment of women prior to starting oral contraceptives (and at regular intervals thereafter) should include a personal and family medical history of each woman. Physical examination should be guided by this and by the contraindications, precautions and warnings for this product. The frequency and nature of these assessments should be based upon relevant guidelines and should be adapted to the individual woman, but should include measurement of blood pressure and, if judged appropriate by the clinician, breast, abdominal and pelvic examination including cervical cytology.
Pregnancy and Lactation
Pregnancy
Estradiol valerate and (estradiol valerate with dienogest) is contraindicated in pregnancy.
Should pregnancy occur, treatment should be discontinued immediately.
Epidemiological studies with ethinylestradiol containing combined oral contraceptives (COCs) have revealed neither an increased risk of birth defects in children born to women who used COCs prior to pregnancy, nor a teratogenic effect when COCs were taken inadvertently during pregnancy. Animal studies do not indicate a risk for reproductive toxicity.
Schaefer (2007) advises that accidental use of oral contraceptives during early pregnancy does not require termination or further diagnostic measures.
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 to 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
Estradiol valerate and (estradiol valerate with dienogest) is contraindicated in breastfeeding.
Manufacturer advises that combined oral contraceptives may adversely affect the quality and quantity of breast milk. Small amount of contraceptive steroids may be excreted within milk and these amounts may affect the child
The use of non-hormonal contraceptive methods is preferred during breastfeeding. It is not recommended to initiate combined hormonal contraceptives until 6 weeks postpartum. During 6 weeks and 6 months postpartum the potential suppression of lactation usually outweighs the advantages of combined hormonal contraceptives. Progestin-only contraceptives are preferred over combined hormonal contraceptives.
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
"Spotting" bleeding
Abdominal pain
Acne
Aggression
Allergic reaction
Alopecia
Amenorrhoea
Anxiety
Arterial thrombosis
Asthma
Attention disturbances
Back pain
Benign breast neoplasm
Breast discomfort
Breast enlargement
Breast neoplasm
Breast secretion
Candidiasis
Cervical dysplasia
Changes in libido
Chest pain
Chloasma
Constipation
Depression
Dermatitis
Diarrhoea
Dizziness
Dysmenorrhoea
Dyspareunia
Dyspepsia
Dysphoria
Dyspnoea
Epistaxis
Eye disorder
Fatigue
Fibrocystic breast changes
Fluid retention
Flushing
Fungal infection
Galactorrhoea
Gastroesophageal reflux disease
Genital bleeding
Headache
Hepatic tumours
Herpes simplex
Hirsutism
Histoplasmosis
Hypersensitivity reactions
Hypertension
Hypertrichosis
Hypertriglyceridaemia
Hypotension
Increase in ALT level
Increased appetite
Increased skin pigmentation
Intolerance to contact lenses
Irritability
Jaw pain
Lability of affect
Lymphadenopathy
Malaise
Menorrhagia
Menstrual disturbances
Mental status changes
Metrorrhagia
Migraine
Mood changes
Muscle spasm
Myocardial infarction
Nausea
Nervousness
Oedema
Ovarian cysts
Palpitations
Paraesthesia
Pelvic inflammatory disease
Pelvic pain
Postcoital bleeding
Premenstrual-like syndrome
Pruritus
Rash
Restlessness
Seborrhoea
Sensation of heaviness
Skin disorder
Sleep disturbances
Urinary tract infections
Uterine bleeding
Uterine fibroids
Uterine spasm
Vaginal discharge
Vaginal odour
Vaginitis
Varicose veins
Venous thrombosis
Vertigo
Vomiting
Vulvovaginal disorders
Weight changes
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 ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).
Further Information
Last Full Review Date: February 2016
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Joint Formulary Committee. British National Formulary. 70th ed. London: BMJ Group and Pharmaceutical Press; 2015.
Summary of Product Characteristics: Qlaira, film-coated tablets. Bayer plc. Revised November 2015.
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
Contraceptives, Oral, Combined. Last revised: 10 December 2015
The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.org
Last revised: 02 November 2015
Last accessed: 22 February 2016
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