Nextstellis
  • About NEXTSTELLIS
    • About E4
    • Mechanism of action
    • An E4-containing COC: 15 mg E4/3 mg DRSP
  • Pharmacodynamics
    • Dose response
    • Endocrine function, metabolic and hemostasis
    • Ovarian function and follicular size
  • Efficacy data
    • Pivotal trials
    • Pearl Index results
  • Safety & tolerability profile
    • Serious warnings and precautions
    • Reported TEAEs
  • Special precautions for disposal
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NEXTSTELLIS SAFETY INFORMATION1

Clinical use:
  • Safety and efficacy have been studied in women between 16 and 50 years old. No data in women under 16 are available. Use of this product before menarche is not indicated.
  • No geriatric data are available. Not authorized for use in women over 50 years of age. NEXTSTELLIS is not indicated for use in postmenopausal women.
Contraindications:
  • NEXTSTELLIS is contraindicated in patients
    • who are hypersensitive to this drug or to any ingredient in the formulation, including any nonmedicinal ingredient, or component of the container
    • who have a history of or actual thrombophlebitis or thromboembolic disorders
    • who have severe or multiple risk factor(s) for arterial or venous or thrombosis, such as hypertension, hereditary or acquired predisposition for venous or arterial thrombosis, such as Factor V Leiden mutation and activated protein C (APC-) resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid-antibodies (anticardiolipin antibodies, lupus anticoagulant) and prothrombin mutation G20210A, severe dyslipoproteinemia, diabetes mellitus with vascular involvement, increasing age, particularly above 50 years, obesity, other medical conditions associated with venous thromboembolism (VTE) or other adverse vascular events, positive family history (arterial thromboembolism [ATE] in a sibling or parent especially at relatively early age, e.g., below 50), prolonged immobilization, major surgery, any surgery to the legs or pelvis, neurosurgery, or major trauma, and smoking, particularly in women who are over 35 years of age
    • who have a history of or actual cerebrovascular disorders
    • who have a history of or actual myocardial infarction or coronary artery disease and valvular heart disease with complications
    • who have a history of or actual prodromi of a thrombosis (e.g., transient ischaemic attack, angina pectoris)
    • who have active liver disease, hepatic dysfunction or history of or actual benign or malignant liver tumours
    • who have known or suspected carcinoma of the breast, carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
    • who have undiagnosed abnormal vaginal bleeding
    • who have steroid-dependent jaundice, cholestatic jaundice, history of jaundice of pregnancy
    • who have any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields
    • with known or suspected pregnancy
    • with current or history of migraine with focal aura
    • with a history of or actual pancreatitis if associated with severe hypertriglyceridaemia
    • who have renal or adrenal insufficiency
Most serious warnings and precautions:
Cardiovascular: Cigarette smoking increases the risk of serious cardiovascular events associated with the use of hormonal contraceptives. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, NEXTSTELLIS should not be used by women who are over 35 years of age and smoke.
Sexually transmitted infections (STIs): Patients should be counselled that birth control pills do not protect against STIs including HIV/AIDS. For protection against STIs, it is advisable to use latex or polyurethane condoms in combination with birth control pills.
Other relevant warnings and precautions:
  • Patients should discontinue NEXTSTELLIS at the earliest manifestation of:
    • thromboembolic and cardiovascular disorders
    • conditions which predispose to venous stasis and to vascular thrombosis
    • visual defects- partial or complete
    • papilledema or ophthalmic vascular lesions
    • severe headache of unknown etiology or worsening of pre-existing migraine headache
    • increase in epileptic seizures
  • Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium should have their serum potassium level checked during the first treatment cycle.
  • NEXTSTELLIS should not be used in patients with conditions that predispose to hyperkalemia (e.g., renal insufficiency, hepatic dysfunction, and adrenal insufficiency).
  • Consider monitoring serum potassium concentration in high-risk patients who take a strong CYP3A4 inhibitor long-term and concomitantly.
  • Women who currently have or have had breast cancer should not use NEXTSTELLIS because breast cancer is a hormonally-sensitive tumour.
  • Increased risk for arterial thromboembolism (myocardial infarction) or for cerebrovascular accident (e.g.,transient ischaemic attack, stroke). Arterial thromboembolic events may be fatal.
  • The use of any COC carries an increased risk of VTE compared with no use – this risk is highest during the first year a woman ever uses a COC or restarts the same or a different COC.
  • For women with multiple risk factors for VTE and ATE: If a woman has more than one risk factor, it is possible that the increase in risk is greater than the sum of the individual factors – in this case her total risk should be considered.
  • Diabetic patients, or those with a family history of diabetes, should be observed closely to detect any worsening of carbohydrate metabolism.
  • Alternative contraception should be used in women with severe dyslipoproteinemia.
  • Worsening of Crohn’s disease and ulcerative colitis has been reported during combined oral contraceptive (COC) use.
  • Persistent irregular vaginal bleeding requires assessment to exclude underlying pathology.
  • Patients with fibroids (leiomyomata) should be carefully observed.
  • Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal.
  • Risk of oral contraceptive-related cholestasis. NEXTSTELLIS should be discontinued if jaundice develops.
  • Caution is warranted when starting therapy with the Hepatitis C virus (HCV) combination drug regimen ombitasvir, paritaprevir, ritonavir, with or without dasabuvir.
  • Patients taking oral contraceptives have a greater risk of developing gallbladder disease requiring surgery within the first year of use. The risk may double after four or five years
  • In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms.
  • Before oral contraceptives are used, a thorough history and physical examination should be performed, including a blood pressure determination and the family case history carefully noted. Disturbances of the clotting system must be ruled out if any members of the family have suffered from thromboembolic diseases (e.g., deep vein thrombosis, stroke, myocardial infarction) at a young age and breasts, liver, extremities, and pelvic organs should be examined and a Papanicolaou (PAP) smear should be taken if the patient has been sexually active. The first follow-up visit should be done 3 months after oral contraceptives are prescribed, and at least once a year, or more frequently if indicated thereafter. Follow-up visit examinations should include those procedures that were done at the initial visit as outlined above or per recommendations of the Canadian Task Force on the Periodic Health Examination. Serum potassium concentration should be monitored in high-risk patients who take a strong CYP3A4 inhibitor long-term and concomitantly.
  • The onset or exacerbation of migraine or the development of headache of a new pattern that is recurrent, persistent, or severe, requires discontinuation of COCs and evaluation of the cause.
  • With use of COCs, there have been reports of retinal vascular thrombosis which may lead to partial or complete loss of vision.
  • There is an increased risk of thromboembolic complications in COC users after major surgery.
  • Patients with a history of emotional disturbances, especially the depressive type, may be more prone to have a recurrence of depression while taking oral contraceptives.
  • Hormonal contraceptives may cause some degree of fluid retention.
  • During the first months of use, irregular spotting or bleeding may occur.
  • Chloasma may occasionally occur in women who take COCs, especially in women with a history of chloasma gravidarum.
  • If pregnancy occurs while taking NEXTSTELLIS, further intake must be stopped.
  • The use of COCs should not be recommended until the breast-feeding mother has completely weaned her child and an alternative contraceptive method should be advised to women wishing to breastfeed
  • The safety and efficacy of NEXTSTELLIS in women with a body mass index (BMI) >35 kg/m2 has not been evaluated.
For more information:
Please consult the Product Monograph at searchlightpharma.com/wp-content/uploads/2023/10/Nextstellis-PM-ENG-Mar2021.pdf for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-855-331-0830.
Searchlight Pharma Inc.
1600 Notre Dame St. West, Suite 312
Montréal, Québec H3J 1M1
NEXTSTELLIS is a trademark of Searchlight Pharma Inc.
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