Pharm

Emergency Contraception

search

Emergency Contraception, Morning After Pill, Postcoital Contraception, Plan B Contraceptive, Ulipristal, Ella

  • Background
  1. As of 2013 may be purchased by anyone in U.S., at any age without a prescription
  2. Previously available from the pharmacy counter without a prescription if age 17 years or older
  3. Ella (Ulipristal acetate) still requires a prescription
  4. Generic single dose and split dose Levonorgestrel
    1. Require a prescription for <17 years old (and are kept behind counter for age 17 and over)
  • Indications
  1. Intercourse within last 120 hours or 5 days (<72 hours offers best efficacy)
    1. Sexual Assault
    2. Failure of ongoing contraceptive method (e.g. broken Condom)
    3. Unprotected Intercourse
  1. Semen remain viable for up to 7 days after ejaculation
  2. Levonorgestrel-based Emergency Contraception effects
    1. Suppresses Ovulation (Follicular Phase <12 days)
    2. Interception by preventing nidation (post Ovulation)
  3. Levonorgestrel has no impact on implanted fetus!
    1. No increase in Spontaneous Abortion rate
    2. No increase in birth defects
    3. No increase in Ectopic Pregnancy
    4. No Teratogenic or other toxic effects
  • Contraindications
  1. Ongoing Pregnancy (No benefit to use)
  2. Past history of thrombosis
    1. Consider Progesterone only option
  3. Concurrent Focal Migraine
  4. Concurrent Lactation (relative contraindication)
  • Protocol
  • Approach
  1. Precautions
    1. FDA and CDC do not direct Emergency Contraception based on weight or BMI (as of 2016)
    2. Guidelines are to offer any of these options
      1. Plan B within 3 days of intercourse OR
      2. Ulipristal within 5 days of intercourse OR
      3. Copper-T IUD
    3. Recommendations listed below are based on expert opinion and differ from FDA and CDC Guidelines
  2. Intercourse not near time of Ovulation AND BMI < 25 AND weight <165 lb
    1. Single dose Plan B - Levonorgestrel method within 3 days of intercourse
  3. Intercourse near time of Ovulation
    1. Single dose Plan B - Levonorgestrel method within 3 days of intercourse AND
    2. Offer copper-T IUD
  4. Body Mass Index (BMI) >25 (but body weight <165 lb)
    1. Single dose Plan B - Levonorgestrel method within 3 days of intercourse AND
    2. Offer copper-T IUD AND
    3. Offer Ulipristal within 5 days of intercourse
  5. Body weight >165 lb or BMI >30 kg/m2
    1. BMI >30 kg/m2 decreases efficacy of Levonorgestrel and Ulipristal
    2. Offer copper-T IUD AND
    3. Offer Ulipristal within 5 days of intercourse
  6. References
    1. Nordt and Swadron in Herbert (2014) EM:Rap 14(8):6
  • Doses
  • New single dose Plan B - Levonorgestrel only method (preferred)
  1. Available OTC for the trade name Levonorgestrel (and behind the counter for the generic single dose option)
  2. Least expensive option ($10 in 2022, compared with $40 for Ella)
  3. Preferred
    1. Kits typically contain 2 white 0.75 Levonorgestrel tablets (1.5 mg total dose)
    2. Levonorgestrel 1.5 mg orally for 1 dose (without Estrogen)
      1. May also be split into two 0.75 mg doses 12 hours apart
      2. Single dose or split dosing have similar efficacy
      3. Cheng (2012) Cochrane Database Syst Rev (8): CD001324 [PubMed]
  4. Preparations (Available as pre-packaged kit)
    1. Plan-B One-Step
    2. Take Action
    3. My Way
    4. Preventeza
  5. Efficacy
    1. Pregnancy rate 2.2% if started within 120 hours (5 days) of intercourse
  6. Adverse Effects
    1. Fewer side effects than traditional method (below)
    2. Bleeding (up to 31%)
    3. Nausea (15%)
    4. Fatigue (15%)
    5. Abdominal Pain (15%)
    6. Headache (10%)
  7. Precautions
    1. See protocol above
    2. Less effective near Ovulation
    3. Less effective if BMI>25 (and not recommended if weight >165 pounds)
  8. References
    1. von Hertzen (2002) Lancet 360:1803-10 [PubMed]
  1. Background
    1. Levonorgestrel is key component for Contraception
      1. Most options below contain Levonorgestrel
      2. Each Norgestrel pill contains 50% Levonorgestrel
    2. Oral Contraceptive: 2 doses, 12 hours apart
      1. Progesterone: Norgestrel, Levonorgestrel 0.5-0.6 mg
      2. Estrogen is not necessary in Emergency Contraception
  2. General
    1. Do not use Placebo pills!
    2. Start dosing so that both doses are during awake time
  3. Option 1: 100 mcg Estrogen/dose (2 tabs q12h x2 doses)
    1. Ovral 2 white pills (0.5 mg Levonorgestrel/dose)
    2. Ogestrel 2 pills (0.5 mg Levonorgestrel/dose)
    3. Preven 2 blue pills (0.5 mg Levonorgestrel/dose)
      1. Contains a total of 4 Ovral tablets
      2. Least expensive option and includes home UPT
  4. Option 2: 120 mcg Estrogen/dose (4 tabs q12h x2 doses)
    1. Lo/Ovral 4 white pills (0.6 mg Levonorgestrel/dose)
    2. Low-Ogestrel 4 tablets (0.5 mg Levonorgestrel/dose)
    3. Nordette 4 light-orange (0.3 mg Levonorgestrel/dose)
    4. Levlen 4 light-orange (0.3 mg Levonorgestrel/dose)
    5. Triphasil 4 Yellow (0.25 mg Levonorgestrel/dose)
    6. Tri-Levlen 4 Yellow (0.25 mg Levonorgestrel/dose)
    7. Levora 4 white pills (0.3 mg Levonorgestrel/dose)
  5. Option 3: 100 mcg Estrogen/dose (5 tabs q12h x2 doses)
    1. Alesse 5 pink pills (0.25 mg Levonorgestrel/dose)
    2. Levlite 5 pink pills (0.25 mg Levonorgestrel/dose)
  6. Pre-packaged kit
    1. Preven (see Option 1 above)
  7. Antiemetic 1 hour before dose
    1. Used for Estrogen induced Nausea
    2. Over the counter
      1. Meclizine (Dimenhydrinate)
      2. Diphenhydramine (Benadryl)
    3. Presciption Antiemetics
      1. Ondansetron (Zofran)
      2. Meclizine (Antivert)
      3. Metoclopramide (Reglan)
      4. Promethazine (Phenergan)
      5. Trimethobenzamide (Tigan)
  • Preparations
  • Alternative agents
  1. Mifepristone
    1. Dose: 10 mg orally for 1 dose
    2. Less effective than Levonorgestrel
  2. Copper-T Intrauterine Device (IUD)
    1. Placed within 120 hours (5 days) of intercourse
    2. Failure rate is <0.1% (when placed within 120 hours, is the most effective Emergency Contraception)
    3. Interferes with fertilization and implantation
    4. Risk includes infection as well as high cost of device and insertion (but no higher risk than standard insertion risks)
    5. Consider for patients wanting both Emergency Contraception as well as long term Contraception
    6. Avoid if high risk for STD such as with Sexual Assault
  3. Mirena IUD (Levonorgestrel-releasing)
    1. Initial studies showed lack of efficacy in Emergency Contraception
    2. However, pregnancy rate 0.3% if inserted within 120 hours (5 days) of intercourse in subsequent studies
      1. Similar efficacy to Copper-T IUD (0.1% pregnancy rate)
      2. Turok (2021) N Engl J Med 384(4): 335-44 [PubMed]
  4. Ulipristal acetate (Ella)
    1. Selective Progesterone receptor modulator (SPRM)
      1. Delays Ovulation as much as 5 days
      2. Effective independent of LH peak (unlike Levonorgestrel)
    2. Dose 30 mg tablet within 120 hours (5 days) of intercourse
    3. Drops pregnancy rate to 1.3% if started within 120 hours of intercourse
    4. Consider in Overweight women (especially if over 165-175 pounds)
    5. As effective as Levonorgestrel single dose or split dose if taken within 72 hours of intercourse
    6. More effective than Levonorgestrel when taken at 72 to 120 hours from time of intercourse (but earliest time is best)
    7. Decreased efficacy in BMI >30% (but more effective than Levonorgestrel in that cohort)
    8. Side effects include Headache, Fatigue and Dysmenorrhea
    9. Avoid Progestins within first 5 days of taking Ulipristal (Ella)
      1. Progestins decrease Ulipristal efficacy for Emergency Contraception
    10. References
      1. Fine (2010) Obstet Gynecol 115(2 pt 1): 257-63 [PubMed]
      2. Glasier (2010) Lancet 375(9714):555-62 [PubMed]
  1. Unprotected intercourse randomly in cycle: >4% pregnancy risk
    1. Risk of pregnancy with Yuzpe method: 2.5 to 2.9%
    2. Number Needed to Treat 50 to prevent one pregnancy (43 with the Levonorgestrel only option)
    3. Leung (2012) Phamacotherapy 32(3): 210-21 [PubMed]
  2. Progestin only method is more effective than OCP method
    1. Example: Plan B (Levonorgestrel only)
    2. (1999) Lancet 352:428-33 [PubMed]
  3. Levonorgestrel has decreased efficacy in weight >165 pounds (and ineffective in weight >175 pounds)
    1. Consider alternative agents listed above
    2. Glasier (2011) Contraception 84(4):363-7 [PubMed]
  4. Advanced Emergency Contraception does not increase unprotected intercourse
    1. Gold (2004) J Pediatr Adolesc Gynecol 17:87-96 [PubMed]
  5. Emergency Contraception efficacy depends on dose timing
    1. Dose taken <12 hours from intercourse: 0.5% pregnancy
    2. Dose taken <24 hours from intercourse: 1.5% pregnancy
    3. Dose taken <36 hours from intercourse: 1.8% pregnancy
    4. Dose taken <48 hours from intercourse: 2.5% pregnancy
    5. Dose taken <60 hours from intercourse: 3.1% pregnancy
    6. Dose taken >60 hours from intercourse: 4.0% pregnancy
    7. Piaggio (1999) Lancet 353:721 [PubMed]
  • Adverse Effects
  1. No evidence for Teratogenicity in case of pregnancy
  2. Most adverse effects associated with Estrogen dose
  3. Nausea (30-54%)
  4. Vomiting (15-20%)
  5. Breast tenderness (12-30%)
  6. Other effects
    1. Headache
    2. Fluid retention
    3. Dizziness
    4. Fatigue
  7. Menstrual effects
  • Management
  • Follow-up
  1. Pregnancy Test in 3 weeks if no Menses, and one week after missed Menses
  2. Longterm Hormonal Contraception may be initiated immediately following Emergency Contraception (same day)
  3. Barrier Contraception (e.g. Condoms) should be used for the first month after taking Ella (Ulipristal acetate)
  • Resources
  • Patient Information
  1. Consider educating patients about Emergency Contraception at routine health visits
  2. Princeton Hotline in English, Spanish
    1. http://not-2-late.com
    2. 1-800-Not-2-Late
  3. Preven
    1. http://www.preven.com
    2. 1-888-Preven2
  4. Emergency Contraception Newsletters
    1. http://cecinfo/html/updates.htm
  • References
  1. Hatcher (1994) Contraceptive Technology P. 415
  2. Nelson (1999) CMEA Gynecology Lecture, San Diego
  3. Bosworth (2014) Am Fam Physician 89(7): 545-9 [PubMed]
  4. Cheng (2012) Cochrane Database Syst Rev (8): CD001324 [PubMed]
  5. Glasier (2011) Contraception 84(4): 363-7 [PubMed]
  6. Paradise (2022) Am Fam Physician 106(3):251-9 [PubMed]
  7. Thomas (2001) Clin Obstet Gynecol 44(1):101-5 [PubMed]
  8. Weismiller (2004) Am Fam Physician 70:707-18 [PubMed]