Diane-35 Drug Interactions

Note: For each co-prescribed medicinal product, the Summary of Product Characteristics should be reviewed for possible interactions.
Effect of other medicinal products on Diane-35: Interactions can occur with active substances that induce microsomal enzymes, which may increase the clearance of sex hormones and lead to breakthrough bleeding and/or contraceptive failure.
Enzyme induction may be observed within a few days of treatment. The maximum enzyme-induced effect is normally observed within a few weeks. The enzyme-induced effect may last for up to 4 weeks after treatment is finished.
Women treated with any such medicinal products should use a barrier method in addition to Diane-35 during this time. The barrier method should be used throughout the period whilst taking the co-medication and for a further 28 days thereafter. If use of the additional barrier method runs beyond the end of the tablets in the Diane-35 pack, tablet-taking should continue from the next Diane-35 pack without the usual 7-day interval.
Substances that increase the clearance of Diane-35 (reduced effectiveness of Diane-35 due to enzyme induction): e.g. barbiturates, rifampicin and antiepileptic drugs (such as barbexaclone, carbamazepine, phenytoin, primidone) and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin and products containing St. John's wort (Hypericum).
Substances with various effects on the clearance of Diane-35: During concomitant use with Diane-35, many HIV/HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors can lead to an increase or decrease in the plasma concentrations of oestrogen or progestogen. These changes may be clinically relevant in some cases.
Substances that reduce the clearance of oestrogen-progestogen combinations (enzyme inhibitors): The clinical relevance of potential interactions with enzyme inhibitors is unknown.
The concomitant administration of potent CYP3A4 inhibitors can increase the plasma concentration of oestrogens or progestogens or both.
At doses of 60 to 120 mg/day, etoricoxib has been shown to increase the plasma concentrations of ethinylestradiol 1.4 to 1.6 fold when taken at the same time as a hormonal contraceptive containing 0.035 mg of ethinylestradiol.
Effect of oestrogen/progestogen combinations on other medicinal products: Oestrogen/progestogen combinations such as Diane-35 can affect the metabolism of certain other medicinal products. Accordingly, plasma levels and tissue concentrations may either increase (e.g. cyclosporin) or decrease (e.g. lamotrigine).
The requirement for antidiabetics can change as a result of the effect on glucose tolerance.
Clinical data suggest that ethinylestradiol inhibits the clearance of CYP1A2 substrates, thereby leading to a slight (e.g. theophylline) or moderate (e.g. tizanidine) rise in the plasma concentration thereof.
Pharmacodynamic interactions: During clinical trials with patients treated for hepatitis C virus infections (HCV) with medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, transaminase (ALT) elevations higher than 5 times the upper limit of normal (ULN) occurred significantly more frequently in women using ethinylestradiol-containing medications such as combined hormonal contraceptives (CHCs).
Additionally, also in patients treated with glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, ALT elevations were observed in women using ethinylestradiol-containing medications such as CHCs (see Contraindications).
Diane-35 users must therefore switch to an alternative method of contraception (e.g. progestogen-only contraception or non-hormonal barrier methods) prior to starting therapy with this combination of medicinal products. Diane-35 can be restarted 2 weeks following completion of treatment with this medicinal product combination.
Other interactions: Laboratory tests: The use of preparations such as Diane-35 may influence the results of certain laboratory tests. This includes biochemical parameters of hepatic, thyroid, adrenal and renal function, as well as the plasma levels of (carrier) proteins, e.g. corticosteroid-binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism, blood coagulation and fibrinolysis. However, these changes generally remain within the normal range.
Note: Diane-35 may not be used with an additional hormonal contraceptive; such medicinal products have to be discontinued prior to starting treatment with Diane-35 (for this, see also Dosage & Administration).