Fusilev (Intravenous)

Levoleucovorin injection is used as a rescue treatment after high-dose methotrexate treatment in patients with osteosarcoma (bone cancer). It is also used to reduce the harmful effects of an overdose of folic acid blockers or methotrexate in patients who cannot remove this drug from their bodies properly. Levoleucovorin injection is also used with fluorouracil to treat metastatic (cancer that has spread) colon or rectal cancer.

This medicine should be given by or under the direct supervision of your doctor.

It is very important that your doctor checks your progress closely while you are receiving this medicine to ensure it is working properly. Blood and urine tests may be needed to look for unwanted effects.

This medicine may cause stomach or bowel problems when used with fluorouracil. Check with your doctor right away if you have any of the following: swelling of the mouth, diarrhea, confusion, decreased urination, dizziness, dry mouth, fainting, increased heart rate, lightheadedness, rapid breathing, sunken eyes, thirst, unusual tiredness or weakness, or wrinkled skin. These symptoms may be severe or last longer than usual.

In deciding to use a medicine, you and your doctor will consider the risks of taking the medicine against the benefits it will provide. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies done so far have not shown any specific problems in children that would limit the use of levoleucovorin injection as a rescue treatment after high-dose methotrexate for osteosarcoma.

However, there have not been studies on how age affects the use of levoleucovorin injection in children for treating metastatic colorectal cancer. The safety and effectiveness have not been established.

Geriatric

Studies done so far have not shown any specific problems in older adults that would limit the usefulness of levoleucovorin injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may need to adjust the dose or take other precautions. When receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are notable but not all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Capecitabine
• Doxifluridine
• Fluorouracil
• Fosphenytoin
• Phenobarbital
• Phenytoin
• Primidone
• Tegafur

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may impact the use of this medicine. Be sure to inform your doctor if you have any other medical conditions, especially:

• Ascites (abnormal fluid in the abdomen) or
• Dehydration or
• Kidney disease or
• Pleural effusion (excess fluid in the lungs)—Use with caution. The dose may need to be increased due to slower removal of methotrexate from the body.

• Hypercalcemia (high calcium in the blood) or
• Stomach or bowel problems (e.g., diarrhea, stomatitis)—Use with caution. This may worsen these conditions.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects will happen, but if they do, they may require medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Belching
• blistering, crusting, irritation, itching, or reddening of the skin
• chest tightness
• cracked, dry, scaly skin
• fever
• heartburn
• indigestion
• sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• stomach discomfort, upset, or pain
• stomach distention
• swelling of the mouth
• troubled breathing
• watery or bloody diarrhea

Incidence not known

• Cough
• difficulty swallowing
• dizziness
• fast heartbeat
• feeling unusually cold
• hives, itching, skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shivering
• unusual tiredness or weakness

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

More common

• Bad unusual or unpleasant (after)taste
• burning, tingling, numbness, or pain in the hands, arms, feet, or legs
• change in taste
• confusion
• decreased appetite
• nausea
• sensation of pins and needles
• stabbing pain
• thinning or loss of hair
• vomiting
• weight loss

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

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

In the U.S.

• Fusilev
• Khapzory

Available Dosage Forms:

• Powder for Solution
• Solution

Therapeutic Class: Methotrexate Rescue

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins.

Do not use this medicine together with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis jiroveci pneumonia in patients with HIV infection.