Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who uses Luveris (Lutropin-alfa). If you are concerned about side effects, discuss the risks and benefits of Luveris (Lutropin-alfa) with your doctor.

The following side effects have been reported by at least 1% of people using Luveris (Lutropin-alfa). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• breast tenderness
• Constipation
• drowsiness
• fatigue
• headache
• nausea, vomiting, or Diarrhea (not continuing or severe)
• pain, redness, itching, swelling at the place of injection
• painful menstruation

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Stop using the medication and seek immediate medical attention if any of the following occur:

• signs of a blood clot in blood vessels (e.g., difficulty breathing, chest pain, pain and swelling in one leg muscle)
• signs of a Anaphylaxis (severe allergic reaction) (e.g., difficulty breathing; Hives; swelling of the mouth, tongue, or throat)
• signs of Stroke (sudden trouble with vision, dizziness, sudden severe and unusual headache, weakness, difficulty speaking)
• symptoms of ovarian hyperstimulation syndrome:
  • abdominal or pelvic discomfort or pain
  • decreased urination
  • diarrhea
  • difficulty breathing
  • nausea
  • rapid weight gain
  • vomiting

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Luveris (Lutropin-alfa).

Each vial of sterile powder contains 75 IU of luteinizing hormone. Nonmedicinal ingredients: sucrose, L-methionine, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, and polysorbate 20. Phosphoric acid and/or sodium hydroxide may be used for pH adjustment.

Do not take lutropin alpha if you:

• are allergic to lutropin alpha, gonadotrophins, or any ingredients of the medication
• are pregnant
• are breast-feeding
• have abnormal uterine bleeding of unknown cause
• have active, untreated tumours of the hypothalamus and pituitary gland
• have an ovarian cyst (not related to polycystic ovarian disease) or have an unknown cause of ovarian enlargement
• have primary ovarian failure
• have sex-hormone (e.g., estrogen) dependent tumours of the reproductive organs or breasts
• have uncontrolled Thyroid or adrenal problems

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Luveris (Lutropin-alfa).

Blood Clots: Luveris (Lutropin-alfa) may increase the chance of blood clot formation causing a reduction of blood flow to the extremities. If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as Heart Attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how Luveris (Lutropin-alfa) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Luveris (Lutropin-alfa), and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.

Multiple births: Multiple births may occur with fertility medications. Talk to your doctor about the risks of multiple births before beginning treatment.

Ovarian enlargement: Some women using Luveris (Lutropin-alfa) may experience ovarian enlargement associated with abdominal bloating or pain. In most cases, these symptoms go away without treatment within 2 or 3 weeks. If you experience these symptoms contact your doctor.

Ovarian hyperstimulation syndrome (OHSS): Treatment with Luveris (Lutropin-alfa) can cause a condition called ovarian hyperstimulation syndrome (OHSS). With OHSS, too many follicles grow and cause abdominal or pelvic discomfort or pain, nausea, vomiting, and weight gain. Some women may experience difficulty breathing and diarrhea. OHSS can progress rapidly and may become serious. If you experience any of these symptoms, contact your doctor immediately.

Pregnancy: The effect of lutropin alpha on an unborn baby is unknown. To avoid the possibility of harm to the baby, Luveris (Lutropin-alfa) should not be used during pregnancy.

Breast-feeding: It is not known if lutropin alpha passes into breast milk. If you are a breast-feeding mother and are taking Luveris (Lutropin-alfa), it may affect your baby. Do not breast-feed while you are taking Luveris (Lutropin-alfa).

Children: Luveris (Lutropin-alfa) is intended for use by women of child-bearing age. Its safety and effectiveness have not been established for children.

Seniors: Luveris (Lutropin-alfa) is intended for use by women of child-bearing age. Its safety and effectiveness have not been established for seniors.