Mozobil

Mozobil is a prescription medication used along with a granulocyte-colony stimulating factor (G-CSF) medication such as filgrastim (Neupogen) or pegfilgrastim (Neulasta) to prepare the blood for an autologous stem cell transplant – a procedure in which blood cells are removed from your body and then returned to the body after chemotherapy and/or radiation. This type of procedure is often used in patients with non-Hodgkin's lymphoma or multiple myeloma, two types of cancer. Mozobil is in a class of medications called hematopoeitic stem cell mobilizers. It works by causing certain blood cells to move from the bone marrow to the blood so that they can be removed for transplant.

Mozobil is available as a solution to be injected subcutaneously (under the skin) by a healthcare professional in a medical facility. It is usually injected once a day, 11 hours before the removal of blood cells, for up to 4 days in a row. Your treatment with Mozobil will begin after you have received a G-CSF medication once a day for 4 days, and you will continue to receive the G-CSF medication during your treatment with Mozobil.

Common side effects of Mozobil include diarrhea, nausea, fatigue, injection site reactions, headache, joint pain, and vomiting.

Mozobil can also cause dizziness. Do not drive or operate heavy machinery until you know how Mozobil affects you.

Mozobil is used along with a granulocyte-colony stimulating factor (G-CSF) medication such as filgrastim (Neupogen) or pegfilgrastim (Neulasta) to prepare the blood for an autologous stem cell transplant – a procedure in which blood cells are removed from your body and then returned to the body after chemotherapy and/or radiation. This type of procedure is often used in patients with non-Hodgkin's lymphoma or multiple myeloma, two types of cancer.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Genzyme Corporation

• Sanofi-Aventis U.S. LLC

Serious side effects have been reported with Mozobil. See the “Mozobil Precautions” section.

Common side effects of Mozobil include the following:

• diarrhea
• nausea
• vomiting
• stomach pain
• fatigue
• injection site reactions (such as pain, redness, hardness, swelling, irritation, itching, bruising, bleeding, numbness, tingling, or rash in the place where Mozobil was injected)
• difficulty falling asleep or staying asleep
• headache
• joint pain
• dizziness

This is not a complete list of Mozobil side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

No Mozobil drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Mozobil including the following:

• Enlargement of the spleen. Tell your healthcare provider right away if you have pain in the left upper part of the stomach or in the shoulder, which could be a symptom of an enlarged spleen.
• Changes in white blood cell and platelet counts. Tell your healthcare provider right away if you experience easy bruising or bleeding.

Also tell your doctor if you experience any of the following symptoms while receiving Mozobil:

• swelling around the eyes
• difficulty breathing
• hives
• fainting

Mozobil can cause dizziness. Do not drive or operate heavy machinery until you know how Mozobil affects you.

Do not take Mozobil if you are allergic to Mozobil or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Mozobil, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Mozobil, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Mozobil or to any of its ingredients
• have or have had leukemia
• have or have had an abnormally high number of neutrophils (a type of blood cell)
• have or have had kidney disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X – are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Mozobil falls into category D.

It has been shown that use of Mozobil in pregnant women caused some babies to be born with problems. However, in some serious situations, the benefit of using this medication may be greater than the risk of harm to the baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Mozobil crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Mozobil.

Take Mozobil exactly as prescribed.

Mozobil is available as a solution to be injected subcutaneously (under the skin) by a healthcare professional in a medical facility. It is usually injected once a day, 11 hours before the removal of blood cells, for up to 4 days in a row. Your treatment with Mozobil will begin after you have received a G-CSF medication once a day for 4 days, and you will continue to receive the G-CSF medication during your treatment with Mozobil.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• your weight

The recommended dose/dose range of Mozobil is 0.24 mg/kg body weight. The dose should be decreased in patients with kidney problems.

If you take too much Mozobil, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Mozobil is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep this and all medicines out of the reach of children.
• Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to Mozobil.