A Women's Health Update
quarter
A Women’s Health Update
JENNA JANUSZKA, PHARMD CANDIDATE 2021
PHILADELPHIA COLLEGE OF PHARMACY Disclosure Slide
No relevant financial relationships or commercial interests to disclose. •List newly FDA- approved women’s health drugs. Objectives •Identify clinical pearls for the appropriate use of these agents. Introduction to Women’s Health
Women hold up half the sky!
-Nicholas Kristof and Sheryl WuDunn
↑ education of pharmacists about contraceptives
1/3 of ALL women’s health continuing education programs listed on PLAN* discuss issues other than contraception
*PLAN: Pharmacists’ Learning Assistance Network Adolescence ENDOMETRIOSIS & UTERINE FIBROIDS and Early Adulthood Elagolix (Orilissa ®)
↓ LH, FSH, and estradiol = ↓ dysmenorrhea and non-menstrual pelvic Mechanism of Action pain associated with endometriosis Contraindicated in pregnancy
Safety & Tolerability Headache, night sweats, amenorrhea, hot flashes, and decreased bone mineral density
Advantages No initial flare symptoms and duration of therapy up to 24 months
No direct comparator trials Disadvantages ↑ Drug interactions Dosing & One tablet (150 mg) PO daily x 24 months in most patients Administration Comparable Drugs: Lupron Depot® (leuprolide), Synarel® (nafarelin)
PO: by mouth Orilissa® [Full Prescribing Information]. Chicago, IL: Abbvie; 2019. Elagolix, ethinyl estradiol, norethindrone (Oriahnn ®)
↓ LH, FSH, and estradiol = ↓ dysmenorrhea and non-menstrual pelvic Mechanism of Action pain associated with uterine fibroids Black Box Warning: Thromboembolic events Contraindicated in pregnancy Safety & Tolerability Amenorrhea, hot flashes, and decreased bone mineral density
Less hypoestrogenic adverse effects than elagolix alone Advantages No initial flare symptoms and duration of therapy up to 24 months Disadvantages No direct comparator trials One white and yellow capsule PO QAM (elagolix + E2 + NETA*) Dosing & Administration One white and light blue capsule PO QPM (elagolix alone) Comparable Drugs: Leuprolide, Synarel® (nafarelin) *E2 + NETA: ethinyl estradiol and norethindrone acetate
PO: by mouth Oriahnn® [Full Prescribing Information]. Chicago, IL: Abbvie; 2020. CONTRACEPTION Adolescence and Early Adulthood Drospirenone (Slynd ®)
Mechanism of Suppresses ovulation Action Hyperkalemia Safety & Tolerability Less likely to cause water retention, breast tenderness, and acne compared to CHCs* 24-hour missed dose window; Advantages contains 4 off days Dosing & One tablet (4mg) PO daily Administration Comparable Progestin-only pills Drugs *CHCs: combined hormonal contraceptives (estrogen + progestin)
PO: by mouth Slynd ® [Full Prescribing Information]. Florham Park, NJ: Exeltis, USA Inc.; 2019. Segesterone acetate, ethinyl estradiol (Annovera ®)
Mechanism of Action Suppresses ovulation UTI and vaginal candidiasis, Safety & Tolerability headache (and migraines), GI symptoms, and dysmenorrhea Advantages Reusable up to 13 cycles
Disadvantages Un-intended expulsion; partner awareness of ring Dosing & Insert ring for 21 consecutive days, then remove for 7; REPEAT x 13 cycles Administration Do not remove for longer than 2 hours cumulatively within a 21-day cycle
Comparable Drugs Etonogesterol/ethinyl estradiol (Nuvaring ™)
Annovera® [Full Prescribing Information]. Boca Raton, FL: TherapeuticsMD, Inc; 2020. L-lactic acid, citric acid, potassium bitartrate (Phexxi ®)
Mechanism of ↓ vaginal pH making an inhospitable environment Action for sperm Warning of ↑ risk of UTI and pyelonephritis Safety Burning and pruritus; male partner discomfort Non-hormonal and on-demand contraception Advantages Trials on-going for use in chlamydia and gonorrhea prevention Must be reapplied if administered > 1 hour before Disadvantages intercourse Pregnancy rate 13.7% on treatment Dosing & Administer one prefilled applicator vaginally Administration immediately before or up to 1 hour prior to intercourse Comparable Drugs Spermicides?
Phexxi® [Full Prescribing Information]. San Diego, CA: Evofem Biosciences, Inc; 2020. Reproductive Years Bremelanotide (Vyleesi ®)
Mechanism of Melanocortin receptor agonist; exact mechanism Action for hypoactive sexual desire disorder unknown Safety & Transient hypertension, focal hyperpigmentation Tolerability On-demand use, no alcohol avoidance, Advantages fewer drug interactions
Disadvantages Subcutaneous administration
Dosing & 1.75 mg subQ in abdomen or thigh at least Administration 45 minutes before intercourse Comparable Flibanserin (Addyi®) Drugs
subQ: subcutaenous Vyleesi® [Full Prescribing Information]. Belgium: AMAG Pharmaceuticals, Inc; 2019. Brexanolone (Zulresso ®)
??? Mechanism of Possibly positive allosteric modulation of GABA Action A for the treatment of postpartum depression Black Box Warning: Safety & Excessive sedation and sudden loss of consciousness Tolerability Low relevant infant dose First FDA-approved treatment Advantages for postpartum depression
Dosing & 60-hour continuous infusion Administration
Comparable Drugs N/A
Zulresso® [Full Prescribing Information]. Cambridge, MA: Sage Therapeutics, Inc.; 2019. Menopause and Beyond Romosozumab (Evenity ®)
Inhibits sclerostin, a regulatory factor in bone Mechanism of Action metabolism, for postmenopausal osteoporosis Safety & Tolerability Black Box Warning: Increased risk of MACE
Advantages Increases bone formation AND decreases bone loss*
Disadvantages Once monthly injection vs. q6 months or daily
Dosing &
Administration
Tymlos® (abaloparatide), Forteo® (teriparatide), Comparable drugs Prolia® (denosumab)
*Effects only seen through 12 months; MACE: major adverse cardiovascular events; q6: every 6 Evenity® [Full Prescribing Information]. Thousand Oaks, CA: Amgen, Inc; 2020 Bio-identical estradiol and progesterone (Bijuva ®)
Mechanism of Maintains estrogen levels to prevent hot flashes Action Black Boxed Warnings: Cardiovascular disorders, breast Safety and endometrial cancers, and probable dementia Breast tenderness, and headache Advantages Bio-identical and single capsule Dosing & One capsule (1mg/100mg) PO daily Administration with evening meal Comparable Duavee® (conjugated estrogens/bazedoxifine), Drugs Provera® (medroxyprogesterone)
PO: by mouth Bijuva® [Full Prescribing Information]. Boca Raton, FL: TherapeuticsMD, Inc; 2019. Women’s Health Pipeline & Honorable Mentions
Indications Honorable Mentions Pipeline
Aimovig®, Ajovy®, Nurtec®, Migraines Qtrypta® Ubrelvy®, Vyepti®, Reyvow®
Contraceptives Twirla® Ovaprene® Phesgo®, Tukysta®, Ennertu®, Breast Cancer Trodelvy®, Nerlynk®, Kadclya®, Ibrance® Piqray®, Herzuma®, Talzenna®
Cervical and Ovarian Cancers Lymparza®, Zejula® -
Endometriosis and Fibroids - Relugolix®, Linzagolix®
Dyspareunia Osphena®, Imvexxy® -
Migraines: Qtrypta (10/20/2020) Contraception: Twirla Breast Cancer Advancements: Phesgo, Tukysa, Trodelvy
What questions do you have for me?
Jenna Januszka [email protected]