Favoir 28

Each pack of Favoir 28 consists of 21 tablets: Each tablet contains Desogestrel (Favoir 28) (a progestogen) 150 mcg and Ethinylestradiol (Favoir 28) (an estrogen) 20 mcg.

Favoir 28 Tablets, USP and Ethinyl Estradiol Tablets, USP are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates.

Favoir 28 combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, Favoir 28, and when taken properly, prevents pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

Favoir 28 does not prevent HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

Favoir 28 is available only with your doctor's prescription.

To achieve maximum contraceptive effectiveness, Favoir 28® (Desogestrel (Favoir 28)/ethinyl estradiol) Tablets must be taken exactly as directed, at the same time every day, and at intervals not exceeding 24 hours. Favoir 28® may be initiated using either a Sunday start or a Day 1 start.

NOTE: Each cycle pack dispenser is preprinted with the days of the week, starting with Sunday, to facilitate a Sunday start regimen. Six different "day label strips" are provided with each cycle pack dispenser in order to accommodate a Day 1 start regimen. In this case, the patient should place the self-adhesive "day label strip" that corresponds to her starting day over the preprinted days.

DURING THE FIRST CYCLE OF USE

IMPORTANT: The possibility of ovulation and conception prior to initiation of use of Favoir 28® should be considered. A woman can begin to take Favoir 28® either on the first Sunday after the onset of her menstrual period (Sunday Start) or on the first day of her menstrual period (Day 1 Start). When switching from another oral contraceptive, Favoir 28® should be started on the same day that a new pack of the previous oral contraceptive would have been started.

SUNDAY START

When initiating a Sunday start regimen, another method of contraception, such as condoms or spermicide, should be used for the first 7 consecutive days of taking Favoir 28®.

Using a Sunday start, tablets are taken daily without interruption as follows: The first light yellow tablet should be taken on the first Sunday after menstruation begins (if menstruation begins on Sunday, the first light yellow tablet is taken on that day). Tablets are then taken sequentially following the arrows marked on the dispenser. One light yellow tablet is taken daily for 7 days, followed by 1 orange tablet daily for 7 days, 1 red tablet daily for 7 days, and then 1 green (inactive) tablet daily for 7 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day (Sunday) after taking the last green (inactive) tablet. [If switching from a Sunday Start oral contraceptive, the first Favoir 28® (Desogestrel (Favoir 28)/ethinyl estradiol) Tablet should be taken on the second Sunday after the last tablet of a 21 day oral contraceptive regimen or should be taken on the first Sunday after the last inactive tablet of a 28 day regimen.]

If a patient misses 1 active tablet in Weeks 1, 2, or 3, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive active tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control (such as condoms or spermicide) if she has intercourse in the 7 days after she restarts her pills. If the patient misses 2 consecutive red (active) tablets in the third week or misses 3 or more active tablets in a row at any time during the cycle, the patient should keep taking 1 active tablet daily until the next Sunday. On Sunday the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after restarting her pills.

Complete instructions to facilitate patient counseling on proper pill usage can be found in Detailed or Brief Patient Labeling ("How to Take the Pill" section).

DAY 1 START

Counting the first day of menstruation as "Day 1", the first light yellow tablet should be taken on the first day of menstrual bleeding. Tablets are then taken sequentially without interruption as follows: One light yellow tablet daily for 7 days, then 1 orange tablet daily for 7 days, followed by 1 red tablet daily for 7 days and then 1 green (inactive) tablet daily for 7 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day after taking the last green (inactive) tablet. [If switching directly from another oral contraceptive, the first light yellow tablet should be taken on the same day that a new pack of the previous oral contraceptive would have been started.]

If a patient misses 1 active tablet in Weeks 1, 2, or 3, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive active tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control (such as condoms or spermicide) if she has intercourse in the 7 days after she restarts her pills. If the patient misses 2 consecutive red tablets in the third week or misses 3 or more active tablets in a row at any time during the cycle, the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after restarting her pills.

Complete instructions to facilitate patient counseling on proper pill usage can be found in Detailed or Brief Patient Labeling ("How to Take the Pill" section).

ADDITIONAL INSTRUCTIONS FOR BOTH SUNDAY AND DAY 1 STARTS

Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, non-functional causes should be considered. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If both pregnancy and pathology have been excluded, time or a change to another preparation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.

Use of Favoir 28® in the Event of a Missed Menstrual Period

1. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and Favoir 28® use should be discontinued if pregnancy is confirmed.
2. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. Favoir 28® should be discontinued if pregnancy is confirmed.

The use of Favoir 28® for contraception may be initiated 4 to 6 weeks postpartum in women who elect not to breast-feed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered.

If the patient starts on Favoir 28® postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a light yellow tablet has been taken daily for 7 consecutive days.

Hypersensitivity to Desogestrel (Favoir 28) and Ethinylestradiol (Favoir 28) or to any of the excipients of Favoir 28.

Combined oral contraceptives should not be used in the presence of any of the conditions listed as follows. Should any of the conditions appear for the 1st time during COC use, Favoir 28 should be stopped immediately.

Presence or a history of venous thrombosis (eg, deep venous thrombosis, pulmonary embolism); presence or history of arterial thrombosis (myocardial infarction, cerebrovascular accident) or prodromal conditions (eg, transient ischemic attack, angina pectoris); known predisposition for venous or arterial thrombosis eg, activated protein C (APC) resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies; history of migraine with focal neurological symptoms; diabetes mellitus with vascular involvement.

The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis may also constitute a contraindication; pancreatitis or a history thereof, if associated with severe hypertriglyceridemia; presence or history of severe hepatic disease as long as liver function values have not returned to normal; cholestatic jaundice; a history of jaundice of pregnancy or jaundice due to the use of steroids; Rotor syndrome and Dubin-Johnson syndrome; presence or history of liver tumors (benign or malignant); known or suspected sex steroid-influenced malignancies (eg, of the genital organs or the breasts); undiagnosed vaginal bleeding; severe hypertension; endometrial hyperplasia; porphyria.

Use in pregnancy: Favoir 28 is not indicated during pregnancy. If pregnancy occurs during treatment with Favoir 28, further intake should be stopped. However, most epidemiological studies 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 early pregnancy.

Use in lactation: Lactation may be influenced by COCs as they may reduce the quantity and change the composition of breast milk. Therefore, the use of COCs should generally not be recommended until the nursing mother has completely weaned the child. Small amounts of the contraceptive steroids and/or their metabolites may be excreted with the milk but there is no evidence that this adversely affects infant health.

Interactions between oral contraceptives and other drugs may lead to breakthrough bleeding and/or oral contraceptive failure. The following interactions have been reported in the literature.

Hepatic Metabolism: Interactions can occur with drugs that induce microsomal enzymes, which can result in increased clearance of sex hormones (eg, hydantoins, barbiturates, primidone, carbamazepine, rifampicin and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and products containing St. John's wort). Maximal enzyme induction is generally not seen for 2-3 weeks but may then be sustained for at least 4 weeks after the cessation of drug therapy.

Contraceptive failures have also been reported with antibiotics eg, ampicillin and tetracyclines. The mechanism of this effect has not been elucidated.

Women on treatment with any of these drugs should temporarily use a barrier method in addition to the combined oral contraceptive (COC) or choose another method of contraception. With microsomal enzyme-inducing drugs, the barrier method should be used during the time of concomitant drug administration and for 28 days after their discontinuation. In case of long-term treatment with microsomal enzyme-inducing drugs, another method of contraception should be considered. Women on treatment with antibiotics (except rifampicin and griseofulvin, which also act as microsomal enzyme-inducing drugs) should use the barrier method until 7 days after discontinuation. If the period during which the barrier method is used runs beyond the end of the tablets in the COC pack, the next COC pack should be started without the usual tablet-free interval.

Oral contraceptives may affect the metabolism of other drugs. Accordingly, plasma and tissue concentrations may either increase (eg, cyclosporin) or decrease (eg, lamotrigine).

Note: The prescribing information of concomitant medications should be consulted to identify potential interactions.

Laboratory Tests: The use of contraceptive steroids may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, plasma levels of (carrier) proteins, eg, corticosteroid-binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. Changes generally remain within the normal laboratory range.

Incompatibilities: Not applicable.

See also:
What are the possible side effects of Favoir 28?

Possibly related undesirable effects that have been reported in users of Favoir 28 or combined oral contraceptive (COC) users in general are listed as follows (The most appropriate MedDRA term version 11.0 to describe a certain adverse reaction is listed. Synonyms or related conditions are not listed, but should be taken into account as well): System Organ Class: Common (>1/100 ); uncommon (>1/1000 and <1/100); rare (<1/1000).

Immune System Disorders: Rare: Hypersensitivity.

Metabolism and Nutrition Disorders: Uncommon: Fluid retention.

Psychiatric Disorders: Common: Depressed and altered mood. Uncommon: Decreased libido. Rare: Increased libido.

Nervous System Disorders: Common: Headache. Uncommon: Migraine.

Eye Disorders: Rare: Contact lens intolerance.

Gastrointestinal Disorders: Common: Nausea, abdominal pain. Uncommon: Vomiting, diarrhoea.

Skin and Subcutaneous Tissue Disorders: Uncommon: Rash, urticaria. Rare: Erythema nodosum, erythema multiforme.

Reproductive System and Breast Disorders: Common: Breast pain, breast tenderness. Uncommon: Breast enlargement. Rare: Vaginal discharge, breast discharge.

Investigations: Common: Increased weight. Rare: Decreased weight.

A number of adverse effects have been reported in women using combined oral contraceptives, which are discussed in more detail in Warnings and Precautions. These include: Venous thromboembolic disorders; arterial thromboembolic disorders; hypertension; hormone-dependent tumours (eg, liver tumours, breast cancer); chloasma; cholelithiasis (gallstone formation), cholestatic jaundice.