Contraindications for the use of Gina
Contraindications for the use of Gina
While in many cases a patient will be considered suitable to start treatment with Gina, there may be occasions when you find that Gina is not suitable due to the presence of a contraindication.
Gina is not suitable for women with contraindicated conditions; these are conditions that could be made worse when using HRT and women with any of these conditions should be referred to their GP for advice and treatment.
Contraindicated conditions are grouped depending on their relevance to local oestrogen therapy or systemic HRT (therefore whether they are specific to Gina or related to class effects of HRT).
Click on each (+) to explore each of the grouped contraindicated conditions:
| Allergy to any of the ingredients, including estradiol or lactose |
Allergic reactions (including anaphylaxis) can result if a woman is allergic to one of the ingredients contained in Gina. It is important to check whether the woman has a known allergy (e.g. an allergy to lactose or estradiol). |
| Vulval dermatoses |
Vulval dermatoses may be a precursor to vulval cancer. Treatment with Gina will not alleviate the symptoms of vulval dermatoses and may delay women receiving medical assessment, diagnosis and effective treatment. Gina is therefore contraindicated in women with vulval dermatoses. |
| Current vaginal infection prior to starting treatment |
Any vaginal infection must be treated before starting treatment with Gina to ensure that concomitant conditions are excluded first. Once the infection is resolved she can be supplied Gina. |
| Vulval rash |
Vulval rash can be a sign of an infection which should be treated before starting treatment with Gina to ensure that concomitant conditions are excluded. |
| Severe vaginal itching (e.g. one that interferes with sleep and daily activities) |
Severe vaginal itching can be associated with vulval dermatoses, which can be a precursor to vulval cancer. Treatment with Gina will not alleviate the symptoms of severe vaginal itching and may delay women receiving medical assessment, diagnosis and effective treatment. |
due to heightened risk of endometrial pathology
| Known, past or suspected endometrial cancer |
Endometrial cancer is sensitive to oestrogen; therefore, Gina is contraindicated. Women should be advised to consult their GP about their symptoms. If they are experiencing vaginal bleeding or spotting, this could be a sign of endometrial cancer.3 |
| Undiagnosed genital bleeding |
Postmenopausal vaginal bleeding could be a sign of endometrial cancer, which is sensitive to oestrogen. Gina is contraindicated in women with endometrial cancer; therefore, it should not be supplied to women with undiagnosed vaginal bleeding and/or spotting. |
| Untreated endometrial hyperplasia |
Untreated endometrial hyperplasia can increase the risk of endometrial cancer. Potential symptoms of endometrial hyperplasia are bleeding or spotting.3 Gina is therefore contraindicated in women with untreated endometrial hyperplasia and should not be supplied. |
| Women with an intact uterus who have previously been treated with unopposed systemic oestrogens |
Long-term use of unopposed systemic oestrogens increases the risk of endometrial hyperplasia and cancer. Endometrial cancer is oestrogen-sensitive and Gina is therefore contraindicated in women with an intact uterus who have previously been treated with systemic oestrogens. |
| Known, past or suspected oestrogen-dependent malignant tumours (e.g. breast or ovarian cancer) |
As Gina contains oestrogen, it is contraindicated for use. Epidemiological evidence from a large meta-analysis suggests no increase in risk of breast cancer in women with no history of breast cancer taking low dose, vaginally applied oestrogens. It is unknown if low dose, vaginal oestrogens stimulate recurrence of breast cancer. |
| Previous or current blood clots in the legs or lungs |
Systemic HRT is associated with a 1.3- to 3-fold risk of developing venous thromboembolism (VTE). Although the risk with local application is less, it is still contraindicated for use. |
| Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction, ischaemic stroke) |
Systemic oestrogen-only therapy is associated with up to a 1.5-fold increase in risk of ischaemic stroke. The risk with local oestrogen is lower; however, it is still contraindicated for use. |
| A thrombophilic disorder/a family history of one (e.g. protein C, protein S or antithrombin deficiency) |
Women with known thrombophilic states have an increased risk of VTE, and systemic HRT may contribute to this risk. Gina use is contraindicated. |
| Porphyria (a rare inherited clotting condition) |
Porphyria may be precipitated by the use of oestrogens. Gina use is contraindicated. |
| Acute liver disease or a history of liver disease (where liver function tests have failed to return to normal) |
Oestrogens are primarily metabolised by hepatic enzymes. Liver impairment therefore can increase HRT exposure and increase the risk of side-effects. There is also a theoretical risk of cholestasis. Gina use is contraindicated. |
Women taking anticoagulants can be supplied Gina. However, it should be confirmed that they are not being taken for a contraindicated condition and women should inform their GP that they have started using Gina at their next routine appointment.1