Phexxi Vaginal Gel 12x5gm
It is used to prevent pregnancy.This drug must be used before you have sex. It will not work if used after you have sex.
Drug Class
Contraceptive, Non-hormonal
Pharmacologic Class
Vaginal pH modulator
Pregnancy Category
Not applicable (contraceptive)
FDA Approved
May 2020
DEA Schedule
Not Controlled
Overview
What is this medicine?
Phexxi is a non-hormonal vaginal gel used to prevent pregnancy. It works by making the vagina more acidic, which stops sperm from moving and fertilizing an egg. You use it right before or up to an hour before sex.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed.
This medication is for vaginal use only. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Apply the medication within 1 hour before each instance of sexual intercourse, as instructed by your doctor.
If you do not have sex within 1 hour after applying the medication, use another dose before engaging in sexual activity.
If you have sex multiple times within 1 hour, use an additional dose each time.
Using This Medication with Other Forms of Birth Control
This medication can be used in conjunction with birth control pills, other hormone-based birth control methods, condoms, and diaphragms. However, do not use this medication with vaginal rings. It can be used at any point during your menstrual cycle.
Special Considerations
You can start using this medication as soon as it is safe to resume sexual activity after a miscarriage, abortion, or giving birth.
Storage and Disposal
To store this medication properly:
Keep it at room temperature in a dry place.
Avoid storing it in a bathroom.
Store the medication in its foil pouch until you are ready to use it.
Keep all medications in a safe location, out of the reach of children and pets.
Missing a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not take two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed.
This medication is for vaginal use only. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Apply the medication within 1 hour before each instance of sexual intercourse, as instructed by your doctor.
If you do not have sex within 1 hour after applying the medication, use another dose before engaging in sexual activity.
If you have sex multiple times within 1 hour, use an additional dose each time.
Using This Medication with Other Forms of Birth Control
This medication can be used in conjunction with birth control pills, other hormone-based birth control methods, condoms, and diaphragms. However, do not use this medication with vaginal rings. It can be used at any point during your menstrual cycle.
Special Considerations
You can start using this medication as soon as it is safe to resume sexual activity after a miscarriage, abortion, or giving birth.
Storage and Disposal
To store this medication properly:
Keep it at room temperature in a dry place.
Avoid storing it in a bathroom.
Store the medication in its foil pouch until you are ready to use it.
Keep all medications in a safe location, out of the reach of children and pets.
Missing a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Administer one dose vaginally immediately before or up to one hour before each act of vaginal intercourse.
- If more than one act of intercourse occurs within one hour, an additional dose must be administered.
- Do not use with vaginal rings (e.g., NuvaRing, Annovera, Eluryng) as it may affect their efficacy or integrity.
- Phexxi does not protect against sexually transmitted infections (STIs).
- May increase the risk of urinary tract infections (UTIs), bacterial vaginosis (BV), and yeast infections in some users.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One pre-filled applicator (5 grams) administered vaginally immediately before or up to one hour before each act of vaginal intercourse.
Dose Range:
5 - 5 mg
Condition-Specific Dosing:
multiple_intercourse:
If more than one act of intercourse occurs within one hour, an additional dose must be administered.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (not indicated for pre-menarcheal females)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Phexxi works by maintaining the vaginal pH in an acidic range (pH 3.5-4.5), which is inhospitable to sperm. This acidic environment immobilizes sperm and reduces their ability to move and fertilize an egg. The active ingredients (lactic acid, citric acid, and potassium bitartrate) are pH regulators that contribute to this effect.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption
Tmax:
Not applicable (local action)
FoodEffect:
Not applicable (vaginal administration)
Distribution:
Vd:
Not applicable (local action)
ProteinBinding:
Not applicable (local action)
CnssPenetration:
No (local action)
Elimination:
HalfLife:
Not applicable (local action, expelled naturally)
Clearance:
Not applicable (local action)
ExcretionRoute:
Vaginal expulsion
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Immediate (upon application)
PeakEffect:
Not applicable (local pH effect)
DurationOfAction:
Up to 1 hour after administration
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a urinary tract infection (UTI), including:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Back pain
Vaginal discharge
Vaginal pain or swelling
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Vaginal burning, discomfort, or itching
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a urinary tract infection (UTI), including:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Back pain
Vaginal discharge
Vaginal pain or swelling
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Vaginal burning, discomfort, or itching
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe vaginal irritation, burning, or itching that does not subside.
- Unusual or foul-smelling vaginal discharge.
- Painful or frequent urination, or other signs of a UTI.
- Abdominal or pelvic pain.
- Any signs of allergic reaction (e.g., rash, swelling, severe dizziness, trouble breathing).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
A history of recurrent urinary tract infections (UTIs) or other urinary tract problems.
* If you are pregnant or think you might be pregnant. Note that this medication is not recommended during pregnancy.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
A history of recurrent urinary tract infections (UTIs) or other urinary tract problems.
* If you are pregnant or think you might be pregnant. Note that this medication is not recommended during pregnancy.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
This medication does not prevent the transmission of diseases such as HIV or hepatitis that can be spread through sexual contact. To minimize the risk of transmission, it is crucial to use a latex or polyurethane condom during any sexual activity. If you have questions or concerns about safe sex practices, consult your doctor.
Your sexual partner may experience side effects such as burning, itching, or pain in the groin or penis area. If these symptoms are severe, advise your partner to contact their doctor for further evaluation and guidance.
If you are breastfeeding, it is important to discuss the potential risks and benefits of this medication with your doctor to determine the best course of action for you and your baby.
This medication does not prevent the transmission of diseases such as HIV or hepatitis that can be spread through sexual contact. To minimize the risk of transmission, it is crucial to use a latex or polyurethane condom during any sexual activity. If you have questions or concerns about safe sex practices, consult your doctor.
Your sexual partner may experience side effects such as burning, itching, or pain in the groin or penis area. If these symptoms are severe, advise your partner to contact their doctor for further evaluation and guidance.
If you are breastfeeding, it is important to discuss the potential risks and benefits of this medication with your doctor to determine the best course of action for you and your baby.
Overdose Information
Overdose Symptoms:
- Not applicable for systemic overdose due to minimal absorption. Local irritation may occur with excessive use.
What to Do:
Discontinue use and irrigate the vagina with water if severe local irritation occurs. For any concerning symptoms, call 1-800-222-1222 (Poison Control) or seek medical attention.
Drug Interactions
Contraindicated Interactions
- Vaginal rings (e.g., NuvaRing, Annovera, Eluryng) - concomitant use is contraindicated due to potential for interaction and impact on ring integrity/efficacy.
Monitoring
Symptom Monitoring
- Vaginal irritation
- Vaginal itching
- Vaginal burning
- Unusual vaginal discharge
- Dysuria (painful urination)
- Urinary frequency
- Signs of urinary tract infection (UTI)
- Signs of bacterial vaginosis (BV)
- Signs of yeast infection
Special Patient Groups
Pregnancy
Phexxi is a contraceptive and is not indicated for use during pregnancy. If pregnancy occurs, Phexxi should be discontinued.
Trimester-Specific Risks:
First Trimester:
Not applicable (contraceptive)
Second Trimester:
Not applicable (contraceptive)
Third Trimester:
Not applicable (contraceptive)
Lactation
Minimal systemic absorption of lactic acid, citric acid, and potassium bitartrate is expected, and therefore, no effects on the breastfed infant or on milk production are anticipated. Considered compatible with breastfeeding.
Infant Risk:
Low risk
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Not indicated for use in pre-menarcheal females.
Geriatric Use
Not applicable. Phexxi is a contraceptive and is not indicated for use in postmenopausal women.
Clinical Information
Clinical Pearls
- Phexxi is a non-hormonal contraceptive option, suitable for individuals who cannot or prefer not to use hormonal methods.
- It must be applied immediately before or up to one hour before each act of intercourse; re-application is necessary for subsequent acts.
- Patients should be counseled on the importance of correct and consistent use for efficacy.
- Phexxi does not protect against STIs; barrier methods (e.g., condoms) should be used for STI prevention.
- Patients should be aware of potential local side effects such as vaginal burning, itching, or irritation, and increased risk of UTIs, BV, or yeast infections.
Alternative Therapies
- Hormonal contraceptives (e.g., oral contraceptives, patches, rings, injections, implants)
- Intrauterine devices (IUDs)
- Barrier methods (e.g., condoms, diaphragms, cervical caps, spermicides)
- Sterilization (tubal ligation, vasectomy)
- Natural family planning methods
Cost & Coverage
Average Cost:
$250 - $350 per 12x5gm box
Insurance Coverage:
Tier 2 or Tier 3 (varies by insurance plan)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist. If you have any questions or concerns about this medication, consult with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.