Refs Why Xatmep? pJIA

References: 1. US FDA/CDER/Office of Compliance. Guidance for Industry: Compounded drug products that are essentially copies of a commercially available drug product under section 503A of the FDCA. January 2018. 2. Sellers S, Utian WH. Pharmacy compounding primer for physicians. Drugs. 2012;72:2043-2050. 3. Xatmep® [prescribing information]. Greenwood Village, CO: Silvergate Pharmaceuticals, Inc.; 2018. 4. Data on file, Silvergate Pharmaceuticals, Inc.; 2018.

Refs Why Xatmep? ALL

References: 1. US FDA/CDER/Office of Compliance. Guidance for Industry: Compounded drug products that are essentially copies of a commercially available drug product under section 503A of the FDCA. January 2018. 2. Sellers S, Utian WH. Pharmacy compounding primer for physicians. Drugs. 2012;72:2043-2050. 3. Xatmep® [prescribing information]. Greenwood Village, CO: Silvergate Pharmaceuticals, Inc.; 2018. 4. Data on file, Silvergate Pharmaceuticals, Inc.; 2018.

ISI Patient pJIA

IMPORTANT SAFETY INFORMATION

This information should not take the place of talking to your doctor about your condition and treatment.
WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY  
Methotrexate can cause the following severe or fatal adverse reactions. Monitor closely and modify dose or discontinue methotrexate as appropriate.
  • Bone marrow suppression [see Warnings and Precautions (5.1)]
  • Serious infections [see Warnings and Precautions (5.2) ]
  • Renal toxicity and increased toxicity with renal impairment [see Warnings and Precautions (5.3)]
  • Gastrointestinal toxicity [see Warnings and Precautions (5.4)]
  • Hepatic toxicity [see Warnings and Precautions (5.5)]
  • Pulmonary toxicity [see Warnings and Precautions (5.6)]
  • Hypersensitivity and dermatologic reactions [see Warnings and Precautions (5.7)]
  • Methotrexate can cause embryo-fetal toxicity, including fetal death. Use in pJIA is contraindicated in pregnancy. Consider the benefits and risks of XATMEP and risks to the fetus when prescribing XATMEP to a pregnant patient with a neoplastic disease. Advise females and males of reproductive potential to use effective contraception during and after treatment with XATMEP [see Contraindications (4), Warnings and Precautions (5.9), Use in Specific Populations (8.1, 8.3)].
 
 

INDICATIONS

Xatmep is a folate analog metabolic inhibitor indicated for the:
    • management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).
    • treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen.

ADDITIONAL IMPORTANT SAFETY INFORMATION

The recommended Xatmep dose is to be taken once weekly. Daily use has resulted in fatal toxicity.   Take Xatmep exactly as your doctor tells you.   An accurate dosing device should always be used. Ask your pharmacist for an accurate dosing device. A household teaspoon is not an accurate dosing device.   Xatmep Oral Solution should not be used if hypersensitive or allergic to methotrexate or any of the ingredients in Xatmep.   Xatmep Oral Solution should not be used during pregnancy in patients with pJIA.   Ask your doctor about the risks to the fetus if you or your partner is taking Xatmep for the treatment of ALL.   Pregnancy should be avoided if either partner is taking Xatmep. Contraception should be used by both females and males while either is taking Xatmep and for 6 months after the last dose taken by females and 3 months after the last dose taken by males.   Xatmep Oral Solution should not be used when nursing.   Methotrexate may affect the ability to have children. Methotrexate may affect menstrual cycles and sperm count.   Discuss vaccinations and immunizations with your doctor prior to receiving them, as they may not be as effective, or should be avoided during methotrexate therapy.   Xatmep may cause severe side effects, including organ toxicity. Organ toxicity may include: bone marrow, kidneys, gastrointestinal, liver, lung, skin, soft tissue and bone. Secondary malignancies may occur. Your doctor will monitor you for signs and symptoms of toxicity during treatment.   Other side effects of methotrexate include:
          • mouth sores
          • diarrhea
          • vomiting
          • abdominal distress
          • fatigue
          • chills
          • fever
          • dizziness
          • decreased resistance to infection
          • leukopenia (decrease in white blood cells)
          • malaise
  These are not all the possible side effects of Xatmep. Your doctor or your patient’s doctor is the best source of advice about side effects.   Call your doctor immediately if you or your patient has any side effects that concern you or do not go away. 

Tell your doctor about any other medications, including prescription and over-the-counter medications, supplements, vitamins, or herbal remedies you are taking. 

Make sure to visit your doctor regularly.   Keep this and all medications out of the reach of children.   Ask your doctor or pharmacist about proper storage and disposal of dispensing bottles and dosing devices.   See full Prescribing Information for further information, including Boxed Warning. You are encouraged to report NEGATIVE SIDE EFFECTS to Silvergate Pharmaceuticals at 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

ISI HCP pJIA

IMPORTANT SAFETY INFORMATION

WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY
    • Methotrexate can cause the following severe or fatal adverse reactions.
    • Monitor closely and modify dose or discontinue methotrexate as appropriate.
  • Bone marrow suppression [see Warnings and Precautions (5.1)]
  • Serious infections [see Warnings and Precautions (5.2)]
  • Renal toxicity and increased toxicity with renal impairment [see Warnings and Precautions (5.3)]
  • Gastrointestinal toxicity [see Warnings and Precautions (5.4)]
  • Hepatic toxicity [see Warnings and Precautions (5.5)]
  • Pulmonary toxicity [see Warnings and Precautions (5.6)]
  • Hypersensitivity and dermatologic reactions [see Warnings and Precautions (5.7)]
  • Methotrexate can cause embryo-fetal toxicity, including fetal death. Use in pJIA is contraindicated in pregnancy. Consider the benefits and risks of XATMEP and risks to the fetus when prescribing XATMEP to a pregnant patient with a neoplastic disease. Advise females and males of reproductive potential to use effective contraception during and after treatment with XATMEP [see Contraindications (4), Warnings and Precautions (5.9), Use in Specific Populations (8.1, 8.3)].
 

INDICATIONS

Xatmep is a folate analog metabolic inhibitor indicated for the:
  • management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).
  • treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen.

ADDITIONAL IMPORTANT SAFETY INFORMATION

Contraindications: Xatmep is contraindicated in pregnant patients with non-malignant disease and in patients with severe hypersensitivity to methotrexate. Warnings and Precautions: See full Prescribing Information for additional information.
  • Xatmep suppresses hematopoiesis and can cause severe and life-threatening pancytopenia, anemia, leukopenia, neutropenia, and thrombocytopenia. Obtain blood counts at baseline and periodically; monitor patients for complications of bone marrow suppression.
  • Patients treated with Xatmep are at increased risk for developing life-threatening or fatal bacterial, fungal, or viral infections, including Pneumocystis jiroveci pneumonia, invasive fungal infections, hepatitis B reactivation, tuberculosis (primary or reactivation), disseminated Herpes zostera> and cytomegalovirus infections.
  • Renal toxicity and increased toxicity with renal impairment, including acute renal failure. Consider administration of glucarpidase in patients with toxic plasma methotrexate concentrations (> 1 micromole/liter) and delayed clearance due to impaired renal function.
  • Xatmep can cause diarrhea, stomatitis, vomiting, hemorrhagic enteritis, and fatal intestinal perforation. Patients with peptic ulcer disease and ulcerative colitis are at increased risk for severe gastrointestinal adverse reactions. Unexpected severe and fatal gastrointestinal toxicity can occur with concomitant use of NSAIDs.
  • Hepatic toxicity: severe and potentially irreversible hepatotoxicity, including fibrosis, cirrhosis, and fatal liver failure can occur. Avoid use of Xatmep in patients with chronic liver disease.
  • Pulmonary toxicity: acute or chronic interstitial pneumonitis and irreversible or fatal cases can occur at all dose levels.
  • Hypersensitivity: anaphylaxis or other serious hypersensitivity reactions. Discontinue methotrexate.
  • Severe, including fatal, dermatologic reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, skin necrosis, erythema multiforme can occur. Radiation dermatitis and sunburn may be “recalled.”
  • Secondary malignancies can occur at all dose levels. Lymphoproliferative disease has been reported with lowdose oral methotrexate which regressed when methotrexate was withdrawn.
  • Methotrexate can cause embryo-fetal toxicity and fetal death when administered during pregnancy. Consider the risks and benefits of Xatmep and risks to the fetus when prescribing to a pregnant patient with a neoplastic disease. Effective contraception should be practiced by patients of reproductive potential while receiving Xatmep therapy, and for 3 and 6 months afterwards for males and females, respectively. Xatmep is contraindicated in pregnant women with non-malignant disease.
  • Effects on reproduction: Methotrexate can cause impairment of fertility, oligospermia, and menstrual dysfunction. It is unknown if the infertility is reversible in affected patients.
  • Increased toxicity in third-space accumulation. Evacuate significant third-space accumulation prior to methotrexate administration.
  • Immunizations may be ineffective when given during Xatmep therapy.
  • Immunization with live virus vaccines is not recommended during Xatmep therapy.
  • Concomitant radiation therapy increases the risk of soft tissue necrosis and osteonecrosis associated with methotrexate.
  • Closely monitor laboratory parameters for hematology, renal function, and liver function. Increase monitoring during initial dosing, dose changes, and during periods of increased risk of elevated methotrexate blood levels (e.g., dehydration).
  • Pulmonary function tests may be useful if methotrexate-induced lung disease is suspected, especially if baseline measurements are available.
  • Risk of improper dosing: Once-weekly dosing is appropriate. Fatal toxicity has been reported with daily dosing. An accurate milliliter measuring device should be used. Inform patients that a household teaspoon is not an accurate measuring device and could lead to overdosage.
  • Advise women not to breastfeed during Xatmep therapy.
Adverse Reactions: See full Prescribing Information for additional adverse reactions.
  • Most common adverse reactions are ulcerative stomatitis, leukopenia, nausea, abdominal distress, and elevated liver function tests.
  • Other frequently reported reactions are malaise, fatigue, chills and fever, dizziness, and decreased resistance to infection.
  • The approximate incidences of adverse reactions reported in pediatric patients with JIA treated with oral, weekly doses of methotrexate (5 to 20 mg/m2week or 0.1 to 0.65 mg/kg/week) were as follows (virtually all patients were receiving concomitant nonsteroidal anti-inflammatory drugs, and some also were taking low doses of corticosteroids): elevated liver function tests, 14%; gastrointestinal reactions (e.g., nausea, vomiting, diarrhea), 11%; stomatitis, 2%; leukopenia, 2%; headache, 1.2%; alopecia, 0.5%; dizziness, 0.2%; and rash, 0.2%. Although there is experience with dosing up to 30 mg/m2/week in JIA, the published data for doses above 20 mg/m2/week are too limited to provide reliable estimates of adverse reaction rates.
Drug Interactions:
  • Penicillins may reduce the clearance of methotrexate; increased serum concentrations of methotrexate with concomitant hematologic and gastrointestinal toxicity have been observed with methotrexate. Monitor patients accordingly.
  • Trimethoprim/sulfamethoxazole has been reported to increase bone marrow suppression in patients receiving methotrexate. Monitor patients accordingly.
  • Hepatotoxins: May increase hepatotoxicity. Monitor patients receiving concomitant hepatotoxins for signs of hepatotoxicity.
  • Probenecid may reduce renal elimination of methotrexate; consider alternative drugs.
  • Nitrous oxide as an anesthetic potentiates the effect of methotrexate resulting in the potential for increased toxicity.
  • NSAIDs, Aspirin, and Steroids: Concomitant administration of Xatmep with NSAIDs, aspirin, or steroids may elevate and prolong methotrexate levels resulting in increased hematologic and gastrointestinal toxicity. Monitor patients accordingly.
  • Theophylline: May decrease theophylline clearance. Monitor theophylline levels.
Please see full Prescribing Information, including Boxed Warning. To report SUSPECTED ADVERSE REACTIONS, contact Silvergate Pharmaceuticals at 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch. Inform caregivers and patients of the need for proper storage and disposal of dispensing bottles and dosing devices. Keep this and all medications out of reach of children.

verification

For information on the treatment of ACUTE LYMPHOBLASTIC LEUKEMIA (ALL), click the appropriate option below, certifying your are either a healthcare provider or a patient or caregiver in the United States.


For information on the treatment of POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (pJIA), click the appropriate option below, certifying your are either a healthcare provider or a patient or caregiver in the United States.

ISI Patient ALL

IMPORTANT SAFETY INFORMATION

This information should not take the place of talking to your doctor about your condition and treatment.
WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY  
Methotrexate can cause the following severe or fatal adverse reactions. Monitor closely and modify dose or discontinue methotrexate as appropriate.
  • Bone marrow suppression [see Warnings and Precautions (5.1)]
  • Serious infections [see Warnings and Precautions (5.2) ]
  • Renal toxicity and increased toxicity with renal impairment [see Warnings and Precautions (5.3)]
  • Gastrointestinal toxicity [see Warnings and Precautions (5.4)]
  • Hepatic toxicity [see Warnings and Precautions (5.5)]
  • Pulmonary toxicity [see Warnings and Precautions (5.6)]
  • Hypersensitivity and dermatologic reactions [see Warnings and Precautions (5.7)]
  • Methotrexate can cause embryo-fetal toxicity, including fetal death. Use in pJIA is contraindicated in pregnancy. Consider the benefits and risks of XATMEP and risks to the fetus when prescribing XATMEP to a pregnant patient with a neoplastic disease. Advise females and males of reproductive potential to use effective contraception during and after treatment with XATMEP [see Contraindications (4), Warnings and Precautions (5.9), Use in Specific Populations (8.1, 8.3)].
 
 

INDICATIONS

Xatmep is a folate analog metabolic inhibitor indicated for the:

  • management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).
  • treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen.

ADDITIONAL IMPORTANT SAFETY INFORMATION

The recommended Xatmep dose is to be taken once weekly. Daily use has resulted in fatal toxicity.

Take Xatmep exactly as your doctor tells you.

An accurate dosing device should always be used. Ask your pharmacist for an accurate dosing device. A household teaspoon is not an accurate dosing device.

Xatmep Oral Solution should not be used if hypersensitive or allergic to methotrexate or any of the ingredients in Xatmep.

Xatmep Oral Solution should not be used during pregnancy in patients with pJIA.

Ask your doctor about the risks to the fetus if you or your partner is taking Xatmep for the treatment of ALL.

Pregnancy should be avoided if either partner is taking Xatmep. Contraception should be used by both females and males while either is taking Xatmep and for 6 months after the last dose taken by females and 3 months after the last dose taken by males.

Xatmep Oral Solution should not be used when nursing.

Methotrexate may affect the ability to have children. Methotrexate may affect menstrual cycles and sperm count.

Discuss vaccinations and immunizations with your doctor prior to receiving them, as they may not be as effective, or should be avoided during methotrexate therapy.

Xatmep may cause severe side effects, including organ toxicity. Organ toxicity may include: bone marrow, kidneys, gastrointestinal, liver, lung, skin, soft tissue and bone. Secondary malignancies may occur. Your doctor will monitor you for signs and symptoms of toxicity during treatment.

Other side effects of methotrexate include:
  • mouth sores
  • diarrhea
  • vomiting
  • abdominal distress
  • fatigue
  • chills
  • fever
  • dizziness
  • decreased resistance to infection
  • leukopenia (decrease in white blood cells)
  • malaise
These are not all the possible side effects of Xatmep. Your doctor or your patient’s doctor is the best source of advice about side effects.

Call your doctor immediately if you or your patient has any side effects that concern you or do not go away. 

Tell your doctor about any other medications, including prescription and over-the-counter medications, supplements, vitamins, or herbal remedies you are taking. 

Make sure to visit your doctor regularly.

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

Ask your doctor or pharmacist about proper storage and disposal of dispensing bottles and dosing devices.

See full Prescribing Information for further information, including Boxed Warning.

You are encouraged to report NEGATIVE SIDE EFFECTS to Silvergate Pharmaceuticals at 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

ISI HCP ALL

IMPORTANT SAFETY INFORMATION

WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY
    • Methotrexate can cause the following severe or fatal adverse reactions.
    Monitor closely and modify dose or discontinue methotrexate as appropriate.
  • Bone marrow suppression [see Warnings and Precautions (5.1)]
  • Serious infections [see Warnings and Precautions (5.2) ]
  • Renal toxicity and increased toxicity with renal impairment [see Warnings and Precautions (5.3)]
  • Gastrointestinal toxicity [see Warnings and Precautions (5.4)]
  • Hepatic toxicity [see Warnings and Precautions (5.5)]
  • Pulmonary toxicity [see Warnings and Precautions (5.6)]
  • Hypersensitivity and dermatologic reactions [see Warnings and Precautions (5.7)]
  • Methotrexate can cause embryo-fetal toxicity, including fetal death. Use in pJIA is contraindicated in pregnancy. Consider the benefits and risks of XATMEP and risks to the fetus when prescribing XATMEP to a pregnant patient with a neoplastic disease. Advise females and males of reproductive potential to use effective contraception during and after treatment with XATMEP [see Contraindications (4), Warnings and Precautions (5.9), Use in Specific Populations (8.1, 8.3)].
 

INDICATIONS

Xatmep is a folate analog metabolic inhibitor indicated for the:
  • treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen.
  • management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).

ADDITIONAL IMPORTANT SAFETY INFORMATION

Contraindications: Xatmep is contraindicated in pregnant patients with non-malignant disease and in patients with severe hypersensitivity to methotrexate.

Warnings and Precautions: See full Prescribing Information for additional information.

  • Xatmep suppresses hematopoiesis and can cause severe and life-threatening pancytopenia, anemia, leukopenia, neutropenia, and thrombocytopenia. Obtain blood counts at baseline and periodically; monitor patients for complications of bone marrow suppression.
  • Patients treated with Xatmep are at increased risk for developing life-threatening or fatal bacterial, fungal, or viral infections, including Pneumocystis jiroveci pneumonia, invasive fungal infections, hepatitis B reactivation, tuberculosis (primary or reactivation), disseminated Herpes zoster and cytomegalovirus infections.
  • Renal toxicity and increased toxicity with renal impairment, including acute renal failure. Consider administration of glucarpidase in patients with toxic plasma methotrexate concentrations (> 1 micromole/liter) and delayed clearance due to impaired renal function.
  • Xatmep can cause diarrhea, stomatitis, vomiting, hemorrhagic enteritis, and fatal intestinal perforation. Patients with peptic ulcer disease and ulcerative colitis are at increased risk for severe gastrointestinal adverse reactions. Unexpected severe and fatal gastrointestinal toxicity can occur with concomitant use of NSAIDs.
  • Hepatic toxicity: severe and potentially irreversible hepatotoxicity, including fibrosis, cirrhosis, and fatal liver failure can occur. Avoid use of Xatmep in patients with chronic liver disease.
  • Pulmonary toxicity: acute or chronic interstitial pneumonitis and irreversible or fatal cases can occur at all dose levels.
  • Hypersensitivity: anaphylaxis or other serious hypersensitivity reactions. Discontinue methotrexate.
  • Severe, including fatal, dermatologic reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, skin necrosis, erythema multiforme can occur. Radiation dermatitis and sunburn may be “recalled.”
  • Secondary malignancies can occur at all dose levels. Lymphoproliferative disease has been reported with lowdose oral methotrexate which regressed when methotrexate was withdrawn.
  • Methotrexate can cause embryo-fetal toxicity and fetal death when administered during pregnancy. Consider the risks and benefits of Xatmep and risks to the fetus when prescribing to a pregnant patient with a neoplastic disease. Effective contraception should be practiced by patients of reproductive potential while receiving Xatmep therapy, and for 3 and 6 months afterwards for males and females, respectively. Xatmep is contraindicated in pregnant women with non-malignant disease.
  • Effects on reproduction: Methotrexate can cause impairment of fertility, oligospermia, and menstrual dysfunction. It is unknown if the infertility is reversible in affected patients.
  • Increased toxicity in third-space accumulation. Evacuate significant third-space accumulation prior to methotrexate administration.
  • Immunizations may be ineffective when given during Xatmep therapy.
  • Immunization with live virus vaccines is not recommended during Xatmep therapy.
  • Concomitant radiation therapy increases the risk of soft tissue necrosis and osteonecrosis associated with methotrexate.
  • Closely monitor laboratory parameters for hematology, renal function, and liver function. Increase monitoring during initial dosing, dose changes, and during periods of increased risk of elevated methotrexate blood levels (e.g., dehydration).
  • Pulmonary function tests may be useful if methotrexate-induced lung disease is suspected, especially if baseline measurements are available.
  • Risk of improper dosing: Once-weekly dosing is appropriate. Fatal toxicity has been reported with daily dosing. An accurate milliliter measuring device should be used. Inform patients that a household teaspoon is not an accurate measuring device and could lead to overdosage.
  • Advise women not to breastfeed during Xatmep therapy.
Adverse Reactions: See full Prescribing Information for additional adverse reactions.
  • Most common adverse reactions are ulcerative stomatitis, leukopenia, nausea, abdominal distress, and elevated liver function tests.
  • Other frequently reported reactions are malaise, fatigue, chills and fever, dizziness, and decreased resistance to infection.
  • The approximate incidences of adverse reactions reported in pediatric patients with JIA treated with oral, weekly doses of methotrexate (5 to 20 mg/m2/week or 0.1 to 0.65 mg/kg/week) were as follows (virtually all patients were receiving concomitant nonsteroidal anti-inflammatory drugs, and some also were taking low doses of corticosteroids): elevated liver function tests, 14%; gastrointestinal reactions (e.g., nausea, vomiting, diarrhea), 11%; stomatitis, 2%; leukopenia, 2%; headache, 1.2%; alopecia, 0.5%; dizziness, 0.2%; and rash, 0.2%. Although there is experience with dosing up to 30 mg/m2/week in JIA, the published data for doses above 20 mg/m2/week are too limited to provide reliable estimates of adverse reaction rates.
Drug Interactions:
  • Penicillins may reduce the clearance of methotrexate; increased serum concentrations of methotrexate with concomitant hematologic and gastrointestinal toxicity have been observed with methotrexate. Monitor patients accordingly.
  • Trimethoprim/sulfamethoxazole has been reported to increase bone marrow suppression in patients receiving methotrexate. Monitor patients accordingly.
  • Hepatotoxins: May increase hepatotoxicity. Monitor patients receiving concomitant hepatotoxins for signs of hepatotoxicity.
  • Probenecid may reduce renal elimination of methotrexate; consider alternative drugs.
  • Nitrous oxide as an anesthetic potentiates the effect of methotrexate resulting in the potential for increased toxicity.
  • NSAIDs, Aspirin, and Steroids: Concomitant administration of Xatmep with NSAIDs, aspirin, or steroids may elevate and prolong methotrexate levels resulting in increased hematologic and gastrointestinal toxicity. Monitor patients accordingly.
  • Theophylline: May decrease theophylline clearance. Monitor theophylline levels.
Please see full Prescribing Information, including Boxed Warning. To report SUSPECTED ADVERSE REACTIONS, contact Silvergate Pharmaceuticals at 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch. Inform caregivers and patients of the need for proper storage and disposal of dispensing bottles and dosing devices. Keep this and all medications out of reach of children.