Delestrogen contains the active ingredient estradiol valerate, which is a long-acting estrogen. It is available as an injection for intramuscular use in two strengths: 20 mg/mL and 40 mg/mL. Key inactive ingredients include benzyl benzoate, benzyl alcohol, and castor oil.

How should I use this medication?

This medication is for injection into a muscle. It is usually given in a hospital or clinic.

A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

Where should I keep my medication?

This medication is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Breast tissue changes, new lumps, redness, pain, or discharge from the nipple
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Heavy vaginal bleeding
• Increase in blood pressure
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Unusual vaginal discharge, itching, or odor

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Bloating
• Breast pain or tenderness
• Dark patches of skin on the face or other sun-exposed areas
• Hair loss
• Irregular menstrual cycles or spotting
• Nausea
• Stomach pain
• Swelling of the ankles, hands, or feet

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have or ever had any of these conditions:

• Abnormal vaginal bleeding
• Blood vessel disease or blood clots
• Cancer
• Gallbladder disease
• Heart disease or recent heart attack
• High blood pressure
• High level of calcium in the blood
• Hysterectomy
• Protein C deficiency
• Protein S deficiency
• An unusual or allergic reaction to estrogens, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following:

• Aromatase inhibitors, such as aminoglutethimide, anastrozole, exemestane, letrozole, testolactone

This medication may also interact with the following:

• Carbamazepine
• Certain antibiotics used to treat infections
• Certain barbiturates or benzodiazepines used for inducing sleep or treating seizures
• Grapefruit juice
• Medications for fungus infections, such as itraconazole and ketoconazole
• Raloxifene or tamoxifen
• Rifabutin, rifampin, or rifapentine
• Ritonavir
• St. John's Wort
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medication. You should also discuss the need for regular mammograms with your care team, and follow their guidelines for these tests.

This medication can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your care team if you feel you are retaining fluid.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects.

Smoking tobacco increases the risk of getting a blood clot or having a stroke while you are taking this medication, especially if you are older than 35 years.

If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your care team.

This medication can increase the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone medication, with this medication lowers the risk of developing this condition. Therefore, if your uterus has not been removed (by a hysterectomy), your care team may prescribe a progestin for you to take together with your estrogen. You should know, however, that taking estrogens with progestins may have additional health risks. You should discuss the use of estrogens and progestins with your care team to determine the benefits and risks for you.

If you are going to have surgery, let your care team know you are receiving estrogen. Consult your care team for advice before you schedule the surgery.

What are the most serious risks of this medication?

Do not use this medicine to prevent heart disease. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, or blood clots.

Estrogens with progestins may increase your chances of getting breast cancer. Talk to your healthcare provider before taking this medicine if you have ever had cancer. Call your healthcare provider right away if you get new breast lumps.

Estrogens with or without progestins may increase your chance of getting dementia based on a study of women 65 years of age or older.

If you have a uterus, using estrogens alone (without progestins) may increase your chance of uterine cancer (cancer of the womb).