Phexxi

Pregnancy Prevention

Phexxi is used as a primary method of birth control to prevent pregnancy. It is categorized as an on-demand contraceptive, meaning it is applied only when needed rather than being taken daily or implanted for long-term use. It is intended for use by females of reproductive potential.

Typical Situations

This medication may be prescribed for individuals who prefer not to use hormonal birth control or who want a method they can use specifically at the time of sexual activity. It can be used as a standalone method or alongside other barrier methods, such as condoms or a diaphragm, for added protection.

Limitations of Use

There are specific situations where Phexxi is not appropriate:

• Not for emergency contraception: It is not effective if used after intercourse. It must be applied before sex occurs to be effective.
• No protection against infections: It does not provide protection against HIV or other sexually transmitted infections (STIs).
• Compatibility: It should not be used at the same time as a contraceptive vaginal ring.

Maintaining Vaginal Acidity

The vagina is naturally acidic, typically maintaining a pH level between 3.5 and 4.5. This environment is naturally hostile to sperm. However, semen is alkaline, and when it enters the vagina, it raises the pH level, making it easier for sperm to survive and swim toward an egg.

Phexxi works by keeping the vaginal pH within its normal acidic range, even after semen is introduced. It contains three active ingredients—lactic acid, citric acid, and potassium bitartrate—that act as a buffering agent to prevent the pH from rising.

Reducing Sperm Motility

By maintaining a low pH, Phexxi creates an environment that decreases sperm motility, which is the sperm's ability to move or swim. When sperm cannot move effectively, they are significantly less likely to travel through the cervix to fertilize an egg.

Unlike many other forms of birth control, Phexxi is non-hormonal. It does not stop ovulation or use hormones to prevent pregnancy; instead, it relies entirely on the physical-chemical environment of the vagina to inhibit sperm function.

Common Side Effects

The most frequently reported side effects of Phexxi involve local irritation in the vaginal area. These may include:

• Vaginal burning, itching, or pain
• Vaginal yeast infections
• Urinary tract infections (UTI)
• Vaginal discharge
• Bacterial vaginosis
• Discomfort or pain during urination

Male partners may also experience local symptoms such as burning, itching, or pain in the genital area following intercourse where Phexxi was used.

Serious Side Effects

While less common, some users may experience more serious complications. Contact a healthcare provider immediately if you experience:

• Signs of a kidney infection, such as fever, chills, or pain in the back or side
• Severe or persistent urinary tract symptoms, such as frequent or painful urination
• Signs of a serious allergic reaction, including rash, swelling (especially of the face, tongue, or throat), severe dizziness, or trouble breathing

Urinary Tract Infections

Serious urinary tract infections have been reported with the use of this product, including bladder infections (cystitis) and kidney infections (pyelonephritis). Because of these risks, this medication is not recommended for individuals who have a history of recurrent urinary tract infections or structural abnormalities of the urinary tract.

Sexually Transmitted Infections

This product is intended for the prevention of pregnancy only. It does not provide protection against HIV/AIDS or other sexually transmitted infections (STIs).

Vaginal Ring Compatibility

This gel should not be used at the same time as the NuvaRing contraceptive vaginal ring. It is compatible with other contraceptive methods, including diaphragms and most condoms, though it should not be used with natural skin (lambskin) condoms.

Hypersensitivity and Irritation

Some users may experience significant vaginal irritation or allergic reactions. If severe local irritation or signs of a hypersensitivity reaction occur, use of the product should be discontinued.

Pregnancy

Phexxi is a birth control method used to prevent pregnancy and has no known use once a pregnancy has started. If you suspect you are pregnant, you should stop using the gel and consult a healthcare professional.

Because the active ingredients in the gel work locally in the vagina and are not absorbed into the body, it is unlikely that exposure during pregnancy would harm a developing fetus. However, clinical trials for this product did not include pregnant individuals, so data on its effects during pregnancy are limited.

Breastfeeding

There is no specific information available regarding the presence of this medication's ingredients in human breast milk or its effects on milk production. Since the gel is not absorbed systemically into the user's bloodstream, it is not expected to pass into breast milk or pose a risk to a breastfeeding infant.

Individuals who are breastfeeding should talk to their healthcare provider about whether this contraceptive method is suitable for their needs.

Dosage Form

Phexxi is available only as a vaginal gel. It is not available in other forms such as oral tablets, patches, or injections.

Strengths and Packaging

The medication is supplied in single-use, pre-filled applicators. Each applicator contains a 5-gram dose of gel consisting of the following active ingredients:

• Lactic acid (1.8%)
• Citric acid (1%)
• Potassium bitartrate (0.4%)

Phexxi is typically distributed in boxes containing 12 applicators. Each applicator is individually wrapped in a foil pouch for single-dose administration.

FDA Approval and Indication

The U.S. Food and Drug Administration (FDA) approved Phexxi in May 2020. It is a non-hormonal prescription gel indicated for the prevention of pregnancy. It is designed for use as an on-demand contraceptive method rather than a daily or long-acting option.

Limitations of Use

Phexxi has specific limitations regarding its effectiveness and use:

• It does not protect against HIV infection or other sexually transmitted infections (STIs).
• It is not recommended for use with vaginal rings.
• It is not effective when administered after intercourse.

Safety Warnings

The FDA-approved labeling includes warnings about the risk of urinary tract infections (UTIs). There have been reports of cystitis and pyelonephritis (kidney infection) associated with its use. Healthcare providers generally advise against using Phexxi in individuals who have a history of recurrent UTIs or anatomical abnormalities of the urinary tract.

Brand-Name Status

Phexxi is a brand-name medication. There is currently no generic version available. Brand-name drugs typically cost more than generic versions because they are protected by patents that prevent other companies from making the same product for a certain period.

Insurance Coverage

The out-of-pocket cost for Phexxi varies significantly based on your health insurance plan. While many insurance plans are required to cover birth control, Phexxi may be listed on different tiers of a plan's formulary (a list of covered drugs). This tier placement determines your co-pay or co-insurance amount. You should contact your insurance provider to confirm if Phexxi is covered and what your specific cost will be.

Factors Influencing Cost

Several factors can affect the price you pay for this medication:

• Pharmacy Selection: Prices can vary between different retail pharmacies and mail-order services.
• Manufacturer Assistance: The company that makes Phexxi may offer savings cards or patient assistance programs to help reduce costs for eligible individuals.
• Prescription Quantity: Phexxi is supplied in boxes of single-dose pre-filled applicators. The total cost will depend on the number of applicators prescribed and purchased at one time.