7129/25, 2:56 PM Silvergate Pharmaceuticals Release: FDA Approves XATMEP, The First and Only Ready-To-Use Methotrexate Oral Solution - BioS...
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`(7 BioSpace
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`News > FDA
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`Silvergate Pharmaceuticals Release: FDA Approves XATMEP,
`The First and Only Ready-To-Use Methotrexate Oral Solution
`
`April 26, 2017 | 6 min read
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`X )l in f M=
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`DENVER, April 26, 2017 /PRNewswire/ -- Silvergate Pharmaceuticals, Inc.
`
`(www.silvergatepharma.com), leaders in the development and commercialization of innovative and
`
`safe medicines for children, today announced that the United States Food and Drug Administration
`(FDA) approved XATMEP (methotrexate) Oral Solution, the first and only FDA-approved
`methotrexate oral solution. XATMEP is indicated for the treatment of acute lymphoblastic leukemia
`
`(ALL) and polyarticular juvenile idiopathic arthritis (pJIA) in pediatric patients.
`
`Silvergate
`
`Pharmaceuticals Inc.
`
`"XATMEP is an exciting product in that it provides an FDA-approved, ready-to-use oral solution of
`methotrexate for children without the need for needles, crushing of tablets or compounding into a
`liquid formulation," said Frank Segrave, President & CEO, Silvergate Pharmaceuticals, Inc. "As a
`company, we continue to focus on pediatric medications that are safe, effective, and readily
`
`available."
`
`XATMEP (methotrexate) Oral Solution, 2.5 mg/mL, is a ready-to-use product that requires no
`preparation, facilitating accuracy and ease of dispensing at the pharmacy. XATMEP is manufactured
`
`under CGMPs in accordance with FDA regulations. It eliminates the need for needles, crushing or
`
`https://www.biospace.com/silvergate-pharmaceuticals-release-fda-approves-xatmep-the-first-and-only-ready-to-use-methotrexate-oral-solution 1/12
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`HELSINN EXHIBIT 2012
`Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.
`Page 1 of 12 IPR2025-00945
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`7/29/25, 2:56 PM Silvergate Pharmaceuticals Release: FDA Approves XATMEP, The First and Only Ready-To-Use Methotrexate Oral Solution - BioS...
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`CALTIIDIVT 1ITLWWUIN VI PHATTTIAuITD dliu a yuallliSu 111ai~uiucl OSTIVILT. 1 VI auJluuvliar innnuviinauvli vii
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`how to obtain XATMEP, please call 1-855-379-0382.
`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.
`About XATMEP
`
`XATMEP (methotrexate) Oral Solution was developed, primarily, to meet the need for a ready-to-
`use, 2.5 mg/mL, methotrexate oral solution for the treatment of pediatric patients for the indications
`stated above. Currently, there is no FDA-approved, ready-to-use oral liquid formulation of
`methotrexate for use by pediatric patients requiring body surface area (BSA) dosing (mg/mz) or who
`have difficulty swallowing or cannot consume tablets, or those with needle-phobia. Silvergate
`Pharmaceuticals, Inc.'s XATMEP (methotrexate) Oral Solution resolves these unmet medical needs
`
`in pediatric patients.
`IMPORTANT SAFETY INFORMATION
`
`XATMEP includes a BOXED WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-
`FETAL TOXICITY
`
`See full prescribing information for complete boxed warning.
`
`Methotrexate can cause severe or fatal toxicities. Monitor closely and modify dose or
`discontinue for the following toxicities: bone marrow suppression (5.1), infection (5.2), renal
`(5.3), gastrointestinal (5.4), hepatic (5.5), pulmonary (5.6), hypersensitivity and dermatologic
`(5.7).
`
`https://www.biospace.com/silvergate-pharmaceuticals-release-fda-approves-xatmep-the-first-and-only-ready-to-use-methotrexate-oral-solution 2/12
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`Page 2 of 12
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`7/29/25, 2:56 PM Silvergate Pharmaceuticals Release: FDA Approves XATMEP, The First and Only Ready-To-Use Methotrexate Oral Solution - BioS...
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`neoplastic disease. Advise patients to use effective contraception during and after treatment
`with XATMEP (5.9, 8.1, 8.3).
`
`ADDITIONAL IMPORTANT SAFETY INFORMATION
`
`XATMEP is contraindicated in patients who are hypersensitive to methotrexate.
`
`XATMEP is contraindicated in patients who are pregnant or nursing.
`
`Warnings and Precautions:
`
`Monitor closely and modify dose or discontinue XATMEP as appropriate.
`Methotrexate can cause the following severe, life-threatening or fatal adverse reactions:
`
`Bone marrow suppression: pancytopenia, anemia, leukopenia, neutropenia, and thrombocytopenia.
`Serious infections: bacterial, fungal, or viral infections, including Pneumocystis jiroveci pneumonia,
`invasive fungal, hepatitis B reactivation, tuberculosis, Herpes zoster and cytomegalovirus infections.
`Renal toxicity and renal impairment, including acute renal failure.
`
`Gastrointestinal toxicity: diarrhea, stomatitis, vomiting, hemorrhagic enteritis, fatal intestinal
`perforation. Unexpected severe and fatal gastrointestinal toxicity can occur with concomitant us of
`NSAIDs.
`
`Hepatic toxicity: severe and potentially irreversible hepatotoxicity, including fibrosis, cirrhosis, and
`fatal liver failure.
`
`Pulmonary toxicity: acute or chronic interstitial pneumonitis and irreversible or fatal cases at all dose
`levels.
`
`Hypersensitivity: anaphylaxis.
`
`Dermatologic reactions: toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative
`dermatitis, skin necrosis, erythema multiforme. Radiation dermatitis and "sunburn" may be recalled.
`Secondary malignancies: lymphoproliferative disease has been reported with low-dose oral
`methotrexate which regressed when methotrexate is withdrawn.
`
`Embryo-fetal toxicity and fetal death: Consider the risks and benefits of XATMEP and risks to the
`fetus when prescribing to a pregnant patient with a neoplastic disease. XATMEP is contraindicated
`
`in non-neoplastic disease.
`
`https://www.biospace.com/silvergate-pharmaceuticals-release-fda-approves-xatmep-the-first-and-only-ready-to-use-methotrexate-oral-solution 3/12
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`7/29/25, 2:56 PM Silvergate Pharmaceuticals Release: FDA Approves XATMEP, The First and Only Ready-To-Use Methotrexate Oral Solution - BioS...
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`9
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`LIISULS Ul ISP UUULLIUI L IVIGU IULGAGLS LAIT LAUSS HHTPAINTISHL Ul IS ULy, UIYUSPSI NG, allu HHISHSU udl
`dysfunction. 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.
`Third-space accumulation: Evacuate significant third-space accumulation prior to methotrexate
`administrations.
`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).
`Improper dosing: Once weekly dosing is appropriate. Fatal toxicity has been reported with daily
`dosing. An accurate millimeter measuring device should be used.
`
`Advise women not to breastfeed.
`
`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
`
`risk to infection.
`
`Drug_Interactions:
`
`Oral antibiotics: Hematologic and gastrointestinal toxicity may increase.
`Hepatotoxins: May increase hepatoxicity.
`Probenecid: Consider alternative drugs as may increase methotrexate exposure.
`
`Theophylline: May reduce theophylline clearance.
`
`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.
`
`Please see accompanying full Prescribing Information, including the complete BOXED
`WARNING.
`
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`7/29/25, 2:56 PM
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`innovative pediatric medications that are safe, effective, and readily available.
`
`Silvergate Pharmaceuticals is committed to filling the unmet needs of children, developing
`innovative medications that will help improve the quality of care and outcomes for pediatric patients.
`
`For more information, please visit http://www.silvergatepharma.com.
`
`Reference: XATMEP [prescribing information]. Greenwood Village, CO: Silvergate
`
`Pharmaceuticals, Inc.; 2017.
`
`Contact
`
`Silvergate Pharmaceuticals, Inc.
`
`Silvergate Pharmaceuticals Release: FDA Approves XATMEP, The First and Only Ready-To-Use Methotrexate Oral Solution - BioS...
`
`(855) 379-0382
`
`silvergatepharma@silvergatepharma.com
`
`(T BioSpace
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`Read more news from Silvergate Pharmaceuticals,_Inc.
`
`http://www.silvergatepharma.com
`
`RA-0344-MTX 170421
`
`To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/fda-
`
`approves-xatmep-the-first-and-only-ready-to-use-methotrexate-oral-solution-300445788.html
`
`SOURCE Silvergate Pharmaceuticals, Inc.
`
`FDA
`
`Approvals
`
`Food and Drug Administration (FDA)
`
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`7/29/25, 2:56 PM Silvergate Pharmaceuticals Release: FDA Approves XATMEP, The First and Only Ready-To-Use Methotrexate Oral Solution - BioS...
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