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NUVARING is a brand name for Etonogestrel, supplied as a ring (slow-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: NUVARING® (etonogestrel/ethinyl estradiol slow release vaginal ring) is indicated for: • Conception control 1.1 Pediatrics Pediatrics (˂18 years of age): The safety and efficacy of NUVARING in adolescents under the age of 18 have not been studied. Use of this product before menarche is not indicated. 1.2 Geriatrics…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Pregnant women: NUVARING should not be used in women who are pregnant. 4 DRUG-DRUG INTERACTION section. • Discontinue medication: Please see 7 WARNINGS AND PRECAUTIONS section. 2 Recommended Dose and Dosage Adjustment To achieve maximum contraceptive effectiveness, NUVARING must be used as directed (see When to Start NUVARING below).
One NUVARING is inserted in the vagina by the woman herself. As NUVARING is designed to be a once-a-month contraceptive regimen the ring is to remain in place continuously for three weeks. It is removed for a one-week break, during which a withdrawal bleed usually occurs.
A new ring is inserted no more than one week after removal of the last ring. NUVARING® (etonogestrel/ethinyl estradiol slow release vaginal ring) Page 6 of 62 Unclassified / Non classifié Advise women to regularly check for the presence of NUVARING in the vagina (for example, before and after intercourse).
3 Drug-Behavioural Interactions, Expulsion). Health Canada has not authorized an indication for pediatric and geriatric use. 4 Administration The user can choose the insertion position that is most comfortable to her, for example, standing with one leg up, squatting, or lying down.
The ring is to be compressed and inserted into the vagina until it feels comfortable. The exact position of NUVARING inside the vagina is not critical for the contraceptive effect of the ring. The vaginal ring must be inserted on the appropriate day and left in place for three consecutive weeks.
This means that the ring is removed three weeks later on the same day of the week as it was inserted and at about the same time. NUVARING can be removed by hooking the index finger under the forward rim or by grasping the rim between the index and middle finger and pulling it out.
The used ring should be placed in the sachet (foil pouch) and discarded in a waste receptacle out of the reach of children and pets (do not flush in toilet). The withdrawal bleeding usually starts 2-3 days after removal of the ring and may not have finished before the next ring is inserted.
In order to maintain contraceptive effectiveness, the new ring must be inserted one week after the previous one was removed even if menstrual bleeding has not finished. For example, if NUVARING is inserted on Wednesday at 22:00 h the ring should be removed again on the Wednesday 3 weeks later at about 22:00 h.
, retinal thrombosis (See 7 WARNINGS AND PRECAUTIONS) NUVARING® (etonogestrel/ethinyl estradiol slow release vaginal ring) Page 17 of 62 Unclassified / Non classifié • Myocardial infarction • Cerebral thrombosis • Cerebral hemorrhage • Hypertension (See 7 WARNINGS AND PRECAUTIONS; 2 CONTRAINDICATIONS) • Benign and malignant hepatic tumors • Gallbladder disease • Congenital anomalies The following adverse reactions also have been reported in patients receiving CHCs: Nausea and vomiting constitute the most common adverse reactions and occur in approximately 10% of patients during the first cycle.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The most common treatment-related adverse events seen in the two pivotal clinical studies were headache, vaginitis, and leukorrhea (Table 2).
These adverse events as well as the incidence of acne, breast tenderness, and nausea which are typical of contraceptives were low. 6 *Total n=2,322 subjects Cervical cytology was assessed in 2,039 women during treatment with NUVARING.
For the majority of subjects, the cervical Pap smear result was Pap I at screening and at last assessment. 3%). Clinically relevant shifts of particular note occurred for 7 subjects with a Pap result of I at screening to a Pap result of IIIb/IV (high-grade SIL) at last assessment.
In summary, changes to abnormal cervical cytology occurred in a low percentage of the subjects. 0%, respectively). 6%, respectively), partly due to the adverse events device-related events and vaginal discomfort, which were only reported in the NUVARING group.
, Cardiovascular and Hematologic): o Severe hypertension (persistent values of ≥160/110 mmHg). o Known predisposition for venous or arterial thrombosis, with or without hereditary involvement such as Activated Protein C (APC-) resistance (including Factor V Leiden), antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
o Severe dyslipoproteinemia. o Smoking, if over age 35. o Diabetes mellitus with vascular involvement (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, Diabetes). o Major surgery with prolonged immobilization (see 7 WARNINGS AND PRECAUTIONS, General).
• History of migraine with focal neurological symptoms (see 7 WARNINGS AND PRECAUTIONS, Neurologic, Migraine and Headache). • Any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields.
NUVARING® (etonogestrel/ethinyl estradiol slow release vaginal ring) Page 5 of 62 Unclassified / Non classifié • 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.
4 Drug-Drug Interactions). • Presence or history of liver tumors (benign or malignant). • Known or suspected malignant conditions of the genital organs or the breasts, if sex steroid- influenced. • Undiagnosed vaginal bleeding. • Known or suspected pregnancy.
• Hypersensitivity to NUVARING or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use.
NUVARING should not be used in the presence of any of the conditions listed below. Should any of the conditions appear for the first time during the use of NUVARING, it should be removed immediately. • Presence or history of venous thrombosis, with or without pulmonary embolism.
, angina pectoris or transient ischemic attack). • Valvular heart disease with complications. • Presence of a severe or multiple risk factor(s) for arterial or venous thrombosis (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular and Hematologic): o Severe hypertension (persistent values of ≥160/110 mmHg).
o Known predisposition for venous or arterial thrombosis, with or without hereditary involvement such as Activated Protein C (APC-) resistance (including Factor V Leiden), antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
o Severe dyslipoproteinemia. o Smoking, if over age 35. o Diabetes mellitus with vascular involvement (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, Diabetes). o Major surgery with prolonged immobilization (see 7 WARNINGS AND PRECAUTIONS, General).
• History of migraine with focal neurological symptoms (see 7 WARNINGS AND PRECAUTIONS, Neurologic, Migraine and Headache). • Any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields.
NUVARING® (etonogestrel/ethinyl estradiol slow release vaginal ring) Page 5 of 62 Unclassified / Non classifié • 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.
4 Drug-Drug Interactions). • Presence or history of liver tumors (benign or malignant). • Known or suspected malignant conditions of the genital organs or the breasts, if sex steroid- influenced. • Undiagnosed vaginal bleeding. • Known or suspected pregnancy.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The following Wednesday a new ring should be inserted.
When to Start NUVARING IMPORTANT:
The possibility of ovulation and conception prior to the first use of NUVARING should be considered. , Day 1-5 of her menstrual bleeding). During the first seven days of NUVARING use in the first cycle, an additional barrier method, such as male condoms or spermicide, is recommended.
Switching from another CHC The woman may switch from her previous combined hormonal contraceptive on any day of the cycle, if she has been using this method consistently and correctly, and if it is reasonably certain that she is not pregnant.
Otherwise, the woman should insert NUVARING at the latest on the day following the usual tablet-free, patch-free or placebo tablet interval of her previous combined hormonal contraceptive. The hormone-free interval of the previous method should never be extended beyond its recommended length.
Switching from a progestin-only method There are several types of progestin-only methods. Women should insert the first NUVARING as follows: • Any day of the month when switching from a progestin-only pill; do not skip any days between the last pill and the first day of NUVARING use • On the same day as contraceptive implant removal • On the same day as removal of a progestin-containing IUD, or • On the day when the next contraceptive injection would be due NUVARING® (etonogestrel/ethinyl estradiol slow release vaginal ring) Page 7 of 62 Unclassified / Non classifié In all of these cases, the patient should be advised to use an additional method of contraception, such as a male condom and/or spermicide, for the first seven days after insertion of the ring.
Following complete first-trimester abortion The woman may start using NUVARING within the first five days following a complete first trimester abortion and does not need to use an additional method of contraception. ” In the meantime she should be advised to use a non-hormonal contraceptive method.
Following delivery or second-trimester abortion The use of NUVARING for contraception may be initiated four weeks after a second trimester abortion or four weeks postpartum in women who elect not to breastfeed. When NUVARING is used postpartum or postabortion, the increased risk of thromboembolic disease must be considered.
(See 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS, Hematologic. ) If a woman begins using NUVARING postpartum, she should be instructed to use an additional method of contraception, such as male condoms or spermicide for the first seven days.
If she has not yet had a period, the possibility of ovulation and conception occurring prior to initiation of NUVARING should be considered. The increased risk of venous thromboembolism (VTE) during postpartum period should be considered when restarting NUVARING (see 7 WARNING AND PRECAUTIONS, Hematologic) Deviations from the Recommended Regimen To […]
Medical and gynecologic examinations performed before and after the studies showed no clinically relevant changes in either group. Heart rate and blood pressure did not change significantly from baseline in either group. Overall, the tolerability of both contraceptives was good (Table 3).
6) Weight increase 4 […]
This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including NUVARING, should not be used by women who are over 35 years of age and smoke (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
• Women should be counselled that NUVARING DOES NOT PROTECT against sexually transmitted infections (STIs) including HIV/AIDS. For protection against STIs, it is advisable to use latex or polyurethane condoms IN COMBINATION WITH NUVARING.
1 Dosing Considerations • Pregnant women: NUVARING should not be used in women who are pregnant. 4 DRUG-DRUG INTERACTION section. • Discontinue medication: Please see 7 WARNINGS AND PRECAUTIONS section. 2 Recommended Dose and Dosage Adjustment To achieve maximum contraceptive effectiveness, NUVARING must be used as directed (see When to Start NUVARING below).
One NUVARING is inserted in the vagina by the woman herself. As NUVARING is designed to be a once-a-month contraceptive regimen the ring is to remain in place continuously for three weeks. It is removed for a one-week break, during which a withdrawal bleed usually occurs.
A new ring is inserted no more than one week after removal of the last ring. NUVARING® (etonogestrel/ethinyl estradiol slow release vaginal ring) Page 6 of 62 Unclassified / Non classifié Advise women to regularly check for the presence of NUVARING in the vagina (for example, before and after intercourse).
3 Drug-Behavioural Interactions, Expulsion). Health Canada has not authorized an indication for pediatric and geriatric use. 4 Administration The user can choose the insertion position that is most comfortable to her, for example, standing with one leg up, squatting, or lying down.
The ring is to be compressed and inserted into the vagina until it feels comfortable. The exact position of NUVARING inside the vagina is not critical for the contraceptive effect of the ring. The vaginal ring must be inserted on the appropriate day and left in place for three consecutive weeks.
This means that the ring is removed three weeks later on the same day of the week as it was inserted and at about the same time. NUVARING can be removed by hooking the index finger under the forward rim or by grasping the rim between the index and middle finger and pulling it out.
The used ring should be placed in the sachet (foil pouch) and discarded in a waste receptacle out of the reach of children and pets (do not flush in toilet). The withdrawal bleeding usually starts 2-3 days after removal of the ring and may not have finished before the next ring is inserted.
In order to maintain contraceptive effectiveness, the new ring must be inserted one week after the previous one was removed even if menstrual bleeding has not finished. For example, if NUVARING is inserted on Wednesday at 22:00 h the ring should be removed again on the Wednesday 3 weeks later at about 22:00 h.
The following Wednesday a new ring should be inserted.
When to Start NUVARING IMPORTANT:
The possibility of ovulation and conception prior to the first use of NUVARING should be considered. , Day 1-5 of her menstrual bleeding). During the first seven days of NUVARING use in the first cycle, an additional barrier method, such as male condoms or spermicide, is recommended.
Switching from another CHC The woman may switch from her previous combined hormonal […]
• Hypersensitivity to NUVARING or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.