This medicine comes with a Patient Information Leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine.

Learn all preparation and usage instructions in the product package. If any of the information is unclear, consult your doctor or pharmacist.

Wash your hands with soap and water before using this medication. Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site daily to avoid discomfort or problem areas under the skin. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Inject this medication under the skin or into a muscle, usually once a day or as directed by your doctor.

The dosage and length of treatment are based on your medical condition, response to treatment, laboratory tests, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor will do blood/medical tests (e.g., estradiol blood levels, ultrasound) to find the right dose for you and to decide when to inject the next medication (hCG).

Headache, nausea, vomiting, mild stomach/abdominal pain, bloating, redness/pain at the injection site, or breast tenderness/pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: unusual bleeding from the vagina/uterus, pain/redness/swelling of the calf muscles, cold/numb/pale skin of the arms/legs/hands/feet, swelling of ankles/hands/feet.

Seek immediate medical attention if any of these rare but very serious side effects occur: weakness on one side of the body, slurred speech, vision changes, sudden severe headache, chest pain, shortness of breath.

This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). This condition may occur during treatment and after treatment has been stopped. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Seek immediate medical attention if you develop the following side effects: severe pain or swelling in the lower abdominal (pelvic) area, severe nausea/vomiting, sudden/rapid weight gain, difficult/painful breathing, decreased urination.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug include: clomiphene, gonadorelin.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Laboratory and/or medical tests (e.g., blood hormone tests such as estradiol level, liver tests, ultrasound) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

It is important to keep all regular medical and laboratory appointments so your doctor can closely monitor your response to help reduce the risk of serious side effects and determine the timing of your hCG dose.

If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule. Do not double the dose to catch up.

Store the unmixed medication in the refrigerator or at room temperature between 37-77 degrees F (3-25 degrees C). Protect from light and moisture. Do not freeze. Do not store in the bathroom. Use immediately after mixing. Discard any unused liquid. Keep all medicines away from children and pets.

It is important that your doctor check your progress at regular visits while you are taking this medicine to make sure that this medicine is working properly. Blood and other tests for the heart may be needed to check for unwanted effects.

Make sure your doctor knows if you are pregnant or planning to become pregnant. Tell your doctor right away if you think you might be pregnant at any time while you are using this medicine. If you are pregnant, make sure your doctor knows if you also have high blood pressure. You and your doctor should discuss whether you should continue to take this medicine during pregnancy.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help.

Check with your doctor right away if you have symptoms of fainting, hallucinations (seeing, hearing, or feeling things that are not there), lightheadedness, stuffy nose, or racing heartbeat.

This medicine may increase your risk of having serious heart, kidney, lung, or stomach problems. Check with your doctor right away if you have chest pain or tightness; extreme tiredness; lower back or side pain; lump or tenderness in the stomach; persistent cough; shortness of breath; troubled breathing; or swelling in your hands, ankles, lower legs, or feet.

Also tell your doctor if you have persistent cough along with shortness of breath or troubled breathing while you are using this medicine. This could be symptoms of a serious lung disorder called pulmonary fibrosis.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor if you start having problems with gambling or increased sex drive while using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

What should I watch for?

Visit your doctor or health care professional for regular checks on your progress.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

This medicine can sometimes cause a temporary drop in blood pressure. This may happen suddenly causing dizziness or light headedness if you try to stand up too quickly. Make sure to get up slowly from a lying or sitting position while taking this medicine.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Common and Rare Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Bloating or swelling of the face, arms, hands, lower legs, or feet

burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings

chills

cold sweats

confusion

dizziness, faintness, or lightheadedness when getting up from lying or sitting position

fast, irregular, pounding, or racing heartbeat or pulse

general feeling of discomfort or illness

rapid weight gain

swelling around the eyes

tingling of the hands or feet

unusual tiredness or weakness

unusual weight gain or loss

Incidence not known

Chest pain or tightness

continuing loss of appetite

continuing or severe abdominal or stomach pain

continuing or severe nausea and vomiting

cough

decreased ability to exercise

fever

increased frequency of urination

loss of appetite

lower abdominal or stomach pain

lower back pain

nausea

shortness of breath

trouble with breathing

vomiting

weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

ymptoms of overdose

Fainting

seeing, hearing, or feeling things that are not there

stuffy nose

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Difficulty having a bowel movement (stool)

dizziness

excess air or gas in the stomach or intestines

full feeling

headache

lack or loss of strength

passing gas

Less common

Abdominal or stomach pain

acid or sour stomach

anxiety

belching

blemishes on the skin

breast pain

burning, itching, or stinging of the skin

changes in vision

cramps

depression

diarrhea

difficulty with moving

dry mouth or toothache

feeling of constant movement of self or surroundings

feeling of warmth

gas

heartburn

heavy bleeding

indigestion

itching skin

joint pain

muscle aches and pains

muscle stiffness

pimples

redness of the face, neck, arms, and occasionally, upper chest

runny nose

sensation of spinning

shivering

sleeplessness

leepiness or unusual drowsiness

sneezing

sore throat

stomach discomfort or upset

sudden sweating

trouble with sleeping

unable to sleep

weight loss

Rare

Bloody nose

difficulty in concentrating

increased in sexual ability, desire, drive, or performance

increased interest in sexual intercourse

Incidence not known

Attack, assault, or force

feeling that others are watching you or controlling your behavior

feeling that others can hear your thoughts

hair loss or thinning of the hair

pathological gambling

severe mood or mental changes

unusual behavior

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.