Xatmep

Xatmep is a prescription medication used to treat acute lymphoblastic leukemia (ALL) and active polyarticular juvenile idiopathic arthritis (pJIA). 

Xatmep belongs to a group of drugs called antimetabolites. These work by inhibiting the immune system and slowing the growth of cancer cells.

Xatmep comes as a solution and is taken by mouth once weekly, with or without food. Xatmep should only be taken orally with an approved measuring device from your healthcare provider or pharmacist. 

Common side effects of Xatmep include stomach ulcers, a decrease in white blood cells, nausea, and stomach pain. 

Xatmep is a prescription medication used to treat acute lymphoblastic leukemia (ALL). ALL is a type of cancer that affects the blood and white blood cells.

Xatmep can also be used to treat polyarticular juvenile idiopathic arthritis (pJIA). PJIA is the most common form of arthritis in children and causes swelling of different joints.

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

• Silvergate Pharmaceuticals, Inc.

Serious side effects have been reported with Xatmep. See the "Xatmep Precautions" sections. 

Common side effects of Xatmep include the following:

• malaise
• fatigue
• chills
• fever
• dizziness
• increased risk of infection

This is not a complete list of Xatmep side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effects that bother you or that do 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.

Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Oral Antibiotics such as amoxicillin (Moxatag), ampicillin (Omnipen), trimethoprim/sulfamethoxazole (Bactrim), cephalexin (Keflex), azithromycin (Zithromax), clindamycin, doxycycline (Vibramycin), ciprofloxacin (Cipro), levofloxacin (Levaquin)
• Liver Toxic Medications such as azathioprine (Azasan), tretinoin (Refissa, Atralin), and sulfasalazine (Azulfidine)

This is not a complete list of Xatmep drug interactions. Ask your doctor or pharmacist for more information. 

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

• Low blood cell counts. This medication can affect your bone marrow and cause you to have low blood cell counts. Your doctor will do blood tests as needed to check your blood cell counts
• Serious infection. This medication can increase your risk of developing life-threatening bacterial or viral infection from opportunistic bacteria. Tell your healthcare provider if you have any of the following symptoms
  • fever 
  • fatigue
  • nausea/vomiting
  • rash
• Decline in kidney function. Toxicity from Xatmep may occur with kidney dysfunction. Your doctor may want to monitor your kidneys with certain blood tests. Tell your healthcare provider right away if you have any of the following symptoms of kidney dysfunction:
  • swelling of face, ankles, hand, or feet
  • fatigue
  • pale skin
  • decreased urination
  • shortness of breath
  • change in blood
• Stomatitis. Notify your healthcare provider right away if you have any of the following symptoms:
  • redness
  • swelling
  • sores in the mouth
• Decline in liver function.  Tell your doctor about any signs or symptoms of liver damage including the following:
  • loss of appetite or weight loss
  • nausea/vomiting
  • feeling tired
  • stomach pain/tenderness
  • dark urine
  • yellowing of the skin or the whites of your eyes
  • fever or rash
• Lung Toxicity. Call your healthcare provider if you experience any of the following symptoms:
  • shortness of breath
  • coughing up mucus
  • chest tightness
  • pain with breathing
• Severe Allergic Reactions. Tell your healthcare provider about any signs or symptoms of severe allergic reaction:
  • chest pain
  • swelling of the face, eyes, lips, tongue, arms, or legs
  • difficulty breathing or swallowing
  • rash
• Secondary Cancers. An increased risk of developing other cancers.
• Harm to Your Unborn Baby. Xatmep can cause harm and potential death to your baby. Consider the risk and benefit of using Xatmep in pregnant women. 
• Live Vaccines. Using live vaccines while on Xatmep is not recommended. Talk to your doctor about which vaccines work best for you.
• Impaired Fertility. Xatmep can cause menstrual dysfunction and affect successful pregnancy.
• Accumulation. Xatmep can accumulate in the space between cells and change how other medications work. You could have increased chance of toxicity or side effects.
• Bone Toxicity. If Xatmep is used at the same time as radiation therapy, there is an increased risk of bone infection. 
• Laboratory Tests. Xatmep therapy requires significant laboratory testing including blood, lung, and liver testing frequently.
• Improper Dosing. The dosing for Xatmep is weekly, not daily. Daily dosing is associated with an increased risk of death or severe side effects. 

Do not take this medication if:

• you are pregnant and do you have a form of cancer

• have a severe allergic reaction to Xatmep or any of its ingredients

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

Before taking Xatmep, tell your doctor about all of your medical conditions. Especially tell your doctor id you: 

• are allergic to Xatmep or any of its ingredients
• have liver problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• are having surgery, including dental surgery

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. 

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

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

Xatmep has been detected in human breast milk in small amounts. Because of the possibility for adverse reactions in nursing infants, a choice should be made whether to stop nursing or to stop the use of Xatmep. The importance of the drug to the mother should be considered. 

Take Xatmep exactly as prescribed. 

Xatmep comes as a oral solution and is taken once a week with or without food. Xatmep should only be taken orally with an approved measuring device from your prescriber or pharmacist. 

If you miss a dose of Xatmep, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Xapmet at the same time. 

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

Xatmep is dosed based on your height and weight for the treatment of ALL and pJIA. Your doctor will adjust your dose based on lab values and side effects you might experience. If you need a higher dose then your doctor might switch you to another medication that your body can absorb more efficiently. 

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

Xatmep can be stored at room temperature or be refrigerated. If kept at room temperature, Xatmep should be discarded after 60 days. 

Keep this and all medicines out of the reach of children. 

WARNING:

• Xatmep should be used only in life threatening neoplastic diseaes, or in patients with psoriasis or rheumatoid athritis with sever, recalcitrant, disabiling disease which is not adequately responsive to other forms of therapy
• Deaths have been reported with the use of Xatmep in the treatment of malignancy, psoriasis, and rheumatoid arthritis. Patients should be closely monitored for bone marrow, liver, lung, and kidney toxicity
• Patients should be informed by their physician of the risks involved and be under a phsycian's care throughout therapy
• Xatmep has been reported to cause fetal death and/or congenital anomalies.Therefore, it is not recommended for women of childbearing potential unless there is clear medical evidence that the benefits can be expected to outweigh the considered risks. Pregnant women with psoriasis or rheumatoid arthritis should not receive methotrexate
• Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and gastrointestinal toxicity have been reported with concomitant administration of methotrexate (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs)
• Xatmep elimination is reduced in patients with impaired renal functions, ascites, or pleural effusions. Such patients require especially careful monitoring for toxicity, and require dose reduction or, in some cases, discontinuation of Xatmep administration
• Xatmep causes hepatotoxicity, fibrosis and cirrhosis, but generally only after prolonged use. Acutely, liver enzyme elevations are frequently seen. These are usually transient and asymptomatic, and also do not appear predictive of subsequent hepatic disease. Liver biopsy after sustained use often shows histologic changes, and fibrosis and cirrhosis have been reported; these latter lesions may not be preceded by symptoms or abnormal liver function tests in the psoriasis population. For this reason, periodic liver biopsies are usually recommended for psoriatic patients who are under long-term treatment. Persistent abnormalities in liver function tests may precede appearance of fibrosis or cirrhosis in the rheumatoid arthritis population
• Xatmep-induced lung disease, including acute or chronic interstitial pneumonitis, is a potentially dangerous lesion, which may occur acutely at any time during therapy and has been reported at low doses. It is not always fully reversible and fatalities have been reported. Pulmonary symptoms (especially a dry, nonproductive cough) may require interruption of treatment and careful investigation
• Diarrhea and ulcerative stomatitis require interruption of therapy: otherwise, hemorrhagic enteritis and death from intestinal perforation may occur. Malignant lymphomas, which may regress following withdrawal of Xatmep, may occur in patients receiving low-dose Xatmep and, thus, may not require cytotoxic treatment. Discontinue methotrexate first and, if the lymphoma does not regress, appropriate treatment should be instituted
• Like other cytotoxic drugs, Xatmep may induce“tumor lysis syndrome” in patients with rapidly growing tumors. Appropriate supportive and pharmacologic measures may prevent or alleviate this complication
• Severe, occasionally fatal, skin reactions have been reported following single or multiple doses of Xatemp. Reactions have occurred within days of oral Xatmep administration. Recovery has been reported with discontinuation of therapy.
• Potentially fatal opportunistic infections, especially Pneumocystis carinii pneumonia, may occur with Xatmep therapy
• Xamep given concomitantly with radiotherapy may increase the risk of soft tissue necrosis and osteonecrosis