Oteseconazole

Oteseconazole is a prescription medication used for treating vulvovaginal candidiasis in women who are not of reproductive potential.

• Oteseconazole is available under various brand names: Vivjoa

Common side effects of Oteseconazole include:

• headache, and 
• nausea.

Serious side effects of Oteseconazole include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• increased blood creatine phosphokinase, 
• indigestion,  
• hot flashes, 
• burning or discomfort with urination, 
• heavy menstrual bleeding lasting more than 7 days, and 
• vulvovaginal irritation (burning, discomfort, or pain)

Rare side effects of Oteseconazole include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule

• 150 mg
• NOTE: Fluconazole is not supplied in cartons

Vulvovaginal Candidiasis

Adult dosage

Oteseconazole-only regimen

• Day 1: 600 mg orally x 1 dose, THEN
• Day 2: 450 mg orally x 1 dose, THEN
• Beginning on Day 14: 150 mg orally every week for 11 weeks (Weeks 2 through 12)

Oteseconazole regimen

• Days 1, 4, and 7: Oteseconazole 150 mg orally for 1 dose, THEN
• Days 14 through 20: Oteseconazole 150 mg orally every day x 7 Days, THEN
• Beginning on Day 28: Oteseconazole 150 mg orally every week for 11 weeks (Weeks 4 through 14)

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Oteseconazole has severe interactions with no other drugs.
• Oteseconazole has serious interactions with the following drugs:
  • pitavastatin
  • rimegepant
• Oteseconazole has moderate interactions with at least 37 other drugs.
• Oteseconazole has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Females of reproductive potential
• Pregnant and lactating females
• Hypersensitivity to oteseconazole

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Oteseconazole?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Oteseconazole?”

Cautions

• Based on animal studies, fetal harm may occur (see Pregnancy & Lactation)
• Drug interaction overview
• Inhibitor of breast cancer resistance protein (BCRP)
• BCRP substrates
• Use the lowest possible starting dose of BCRP substrate, or consider reducing BCRP substrate dose; monitor adverse reactions
• Oteseconazole may increase the effects and toxicities of BCRP substrates

Pregnancy & Lactation

• Contraindicated in females of reproductive potential and in pregnant females
• The drug exposure window is ~690 days (based on 5x the half-life of oteseconazole) to prevent any risks of embryofetal toxicities
• Lactation
  • Contraindicated in lactating females
  • There are no data on the presence of oteseconazole in human or animal milk or its effects on milk production
  • There were no reported adverse effects in breastfed infants following maternal exposure to oteseconazole during lactation
  • Owing to the limited duration of follow-up of oteseconazole-exposed infants during the postnatal period, no conclusions can be drawn from the data.