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Reason for Use code 378 For the post-operative prophylaxis of venous thromboembolic events in patients undergoing orthopedic surgery of the lower limbs such as hip fracture, hip replacement or knee surgery. Coverage limit: Limited to 9 days of reimbursement. Coverage limit: LU Authorization Period: 1 year Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Fondaparinux Brand(s): Arixtra and generic DOSAGE FORM/ STRENGTH: 2.5 mg For the post-operative prophylaxis of venous thromboembolism following abdominal or pelvic surgery for cancer. Standard Approval Duration: Maximum of 30 days Fondaparinux Brand(s): Arixtra (2.5mg) and Generic (2.5mg and 7.5mg) Check formulary or e- formulary for funded products DOSAGE FORM/ STRENGTH: 2.5 mg and 7.5 mg For the treatment of venous thromboembolism (VTE) [deep vein thrombosis (DVT), pulmonary embolism (PE)] in the setting of acute heparin induced thrombocytopenia (HIT) Duration: 1 month if patient is able to transition to warfarin OR up to 1 year for patients who cannot be managed on warfarin* 29 Fondaparinux Brand(s): Arixtra (2.5mg) and Generic (2.5mg and 7.5mg) Check formulary or e- formulary for funded products DOSAGE FORM/ STRENGTH: 2.5mg and 7.mg Injection For the treatment of venous thromboembolism (VTE) [deep vein thrombosis (DVT), pulmonary embolism (PE)] in patients with previous HIT who cannot use rivaroxaban Duration: 1 month if patient is able to transition to warfarin OR up to 1 year for patients who cannot be managed on warfarin* * Patients may not be able to use warfarin as extended treatment or prophylaxis of VTE due to contraindication, previous clinical failure, inability to swallow/ take oral medications, immobility, inability to monitor INR, etc. The reasons why warfarin is not appropriate must be clearly described. Renewal of funding for the above indications may be considered on a case-by-case basis with documented clinical rationale that includes details pertaining to patient’s risks for recurrent VTE, risks of bleeding, update on whether warfarin therapy may now be considered, and response to therapy. For peri-operative bridging for patients with history of HIT who require long-term warfarin therapy and must temporarily discontinue it before and after surgery, and who are at moderate- to high-risk for an embolic event while off warfarin. Duration: As requested up to a maximum of 10 days before the date of surgery plus up to 7 days after surgery Renewal of funding will NOT be considered for this indication. EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 29, record 9, corpus 2025-01-01; name match only, not an eligibility decision

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Arixtra · DIN 02245531 Manufacturer: Aspen Pharma Trading Limited; listing date 2004-04-06 Health Canada: Marketed since 2018-07-10 · brand ARIXTRA · ATC B01AX05 FONDAPARINUX · form Solution · route Intravenous, Subcutaneous · ingredients FONDAPARINUX SODIUM 2.5 MG/0.5ML · company Aspen pharmacare canada inc. · schedule Prescription

DIN 02245531: Arixtra Raw flags: sec12=Y, sec3=Y Item: 201200072; group id 256; item number 0497; lccId 00148; manufacturer id ASN Source form: Inj Sol-Pref Syr 0.5mL Pk (Preservative Free); strength: 2.5mg/0.5mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $13.4642; ministry $11.1944 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02245531 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=69618

Interchangeable products

Fondaparinux Sodium Injection · DIN 02406853 · $11.1944

Shortage status: avoided shortage; reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02245531

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Reason for Use code 378 For the post-operative prophylaxis of venous thromboembolic events in patients undergoing orthopedic surgery of the lower limbs such as hip fracture, hip replacement or knee surgery. Coverage limit: Limited to 9 days of reimbursement. Coverage limit: LU Authorization Period: 1 year Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Fondaparinux Brand(s): Arixtra and generic DOSAGE FORM/ STRENGTH: 2.5 mg For the post-operative prophylaxis of venous thromboembolism following abdominal or pelvic surgery for cancer. Standard Approval Duration: Maximum of 30 days Fondaparinux Brand(s): Arixtra (2.5mg) and Generic (2.5mg and 7.5mg) Check formulary or e- formulary for funded products DOSAGE FORM/ STRENGTH: 2.5 mg and 7.5 mg For the treatment of venous thromboembolism (VTE) [deep vein thrombosis (DVT), pulmonary embolism (PE)] in the setting of acute heparin induced thrombocytopenia (HIT) Duration: 1 month if patient is able to transition to warfarin OR up to 1 year for patients who cannot be managed on warfarin* 29 Fondaparinux Brand(s): Arixtra (2.5mg) and Generic (2.5mg and 7.5mg) Check formulary or e- formulary for funded products DOSAGE FORM/ STRENGTH: 2.5mg and 7.mg Injection For the treatment of venous thromboembolism (VTE) [deep vein thrombosis (DVT), pulmonary embolism (PE)] in patients with previous HIT who cannot use rivaroxaban Duration: 1 month if patient is able to transition to warfarin OR up to 1 year for patients who cannot be managed on warfarin* * Patients may not be able to use warfarin as extended treatment or prophylaxis of VTE due to contraindication, previous clinical failure, inability to swallow/ take oral medications, immobility, inability to monitor INR, etc. The reasons why warfarin is not appropriate must be clearly described. Renewal of funding for the above indications may be considered on a case-by-case basis with documented clinical rationale that includes details pertaining to patient’s risks for recurrent VTE, risks of bleeding, update on whether warfarin therapy may now be considered, and response to therapy. For peri-operative bridging for patients with history of HIT who require long-term warfarin therapy and must temporarily discontinue it before and after surgery, and who are at moderate- to high-risk for an embolic event while off warfarin. Duration: As requested up to a maximum of 10 days before the date of surgery plus up to 7 days after surgery Renewal of funding will NOT be considered for this indication. EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 29, record 9, corpus 2025-01-01; name match only, not an eligibility decision

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Fondaparinux Sodium Injection · DIN 02406853 Manufacturer: Dr. Reddy's Laboratories Inc.; listing date 2014-07-30 Health Canada: Marketed since 2014-03-21 · brand FONDAPARINUX SODIUM INJECTION · ATC B01AX05 FONDAPARINUX · form Solution · route Subcutaneous, Intravenous · ingredients FONDAPARINUX SODIUM 2.5 MG/0.5ML · company Dr reddy's laboratories ltd · schedule Prescription

DIN 02406853: Fondaparinux Sodium Injection Raw flags: sec12=Y, sec3=Y Item: 201200072; group id 256; item number 0497; lccId 00148; manufacturer id DRR Source form: Inj Sol-Pref Syr 0.5mL Pk (Preservative Free); strength: 2.5mg/0.5mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $11.1944; ministry $11.1944 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02406853 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=89154

Interchangeable products

Arixtra · DIN 02245531 · $11.1944

Shortage status: resolved shortage (ended 2021-12-03); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02406853

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Exceptional Access criteria on record are for Brand(s): Arixtra and generic; DOSAGE FORM/ STRENGTH: 2.5 mg — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Fondaparinux Brand(s): Arixtra and generic DOSAGE FORM/ STRENGTH: 2.5 mg For the post-operative prophylaxis of venous thromboembolism following abdominal or pelvic surgery for cancer. Standard Approval Duration: Maximum of 30 days Fondaparinux Brand(s): Arixtra (2.5mg) and Generic (2.5mg and 7.5mg) Check formulary or e- formulary for funded products DOSAGE FORM/ STRENGTH: 2.5 mg and 7.5 mg For the treatment of venous thromboembolism (VTE) [deep vein thrombosis (DVT), pulmonary embolism (PE)] in the setting of acute heparin induced thrombocytopenia (HIT) Duration: 1 month if patient is able to transition to warfarin OR up to 1 year for patients who cannot be managed on warfarin* 29 Fondaparinux Brand(s): Arixtra (2.5mg) and Generic (2.5mg and 7.5mg) Check formulary or e- formulary for funded products DOSAGE FORM/ STRENGTH: 2.5mg and 7.mg Injection For the treatment of venous thromboembolism (VTE) [deep vein thrombosis (DVT), pulmonary embolism (PE)] in patients with previous HIT who cannot use rivaroxaban Duration: 1 month if patient is able to transition to warfarin OR up to 1 year for patients who cannot be managed on warfarin* * Patients may not be able to use warfarin as extended treatment or prophylaxis of VTE due to contraindication, previous clinical failure, inability to swallow/ take oral medications, immobility, inability to monitor INR, etc. The reasons why warfarin is not appropriate must be clearly described. Renewal of funding for the above indications may be considered on a case-by-case basis with documented clinical rationale that includes details pertaining to patient’s risks for recurrent VTE, risks of bleeding, update on whether warfarin therapy may now be considered, and response to therapy. For peri-operative bridging for patients with history of HIT who require long-term warfarin therapy and must temporarily discontinue it before and after surgery, and who are at moderate- to high-risk for an embolic event while off warfarin. Duration: As requested up to a maximum of 10 days before the date of surgery plus up to 7 days after surgery Renewal of funding will NOT be considered for this indication. EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 29, record 9, corpus 2025-01-01; name match only, not an eligibility decision

Arixtra · DIN 02258056 Manufacturer: Aspen Pharma Trading Limited; listing date 2014-07-30 Health Canada: Marketed since 2018-07-17 · brand ARIXTRA · ATC B01AX05 FONDAPARINUX · form Solution · route Subcutaneous · ingredients FONDAPARINUX SODIUM 7.5 MG/0.6ML · company Aspen pharmacare canada inc. · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02258056). DIN 02258056: Arixtra Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 201200080; group id 257; item number 0498; lccId None; manufacturer id ASN Source form: Inj Sol-Pref Syr 0.6mL Pk (Preservative Free); strength: 7.5mg/0.6mL Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): not recorded; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02258056 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=74328

Interchangeable products

Fondaparinux Sodium Injection · DIN 02406896 · $18.1356

Shortage status: resolved shortage (ended 2018-07-20); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02258056

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Exceptional Access criteria on record are for Brand(s): Arixtra and generic; DOSAGE FORM/ STRENGTH: 2.5 mg — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Fondaparinux Brand(s): Arixtra and generic DOSAGE FORM/ STRENGTH: 2.5 mg For the post-operative prophylaxis of venous thromboembolism following abdominal or pelvic surgery for cancer. Standard Approval Duration: Maximum of 30 days Fondaparinux Brand(s): Arixtra (2.5mg) and Generic (2.5mg and 7.5mg) Check formulary or e- formulary for funded products DOSAGE FORM/ STRENGTH: 2.5 mg and 7.5 mg For the treatment of venous thromboembolism (VTE) [deep vein thrombosis (DVT), pulmonary embolism (PE)] in the setting of acute heparin induced thrombocytopenia (HIT) Duration: 1 month if patient is able to transition to warfarin OR up to 1 year for patients who cannot be managed on warfarin* 29 Fondaparinux Brand(s): Arixtra (2.5mg) and Generic (2.5mg and 7.5mg) Check formulary or e- formulary for funded products DOSAGE FORM/ STRENGTH: 2.5mg and 7.mg Injection For the treatment of venous thromboembolism (VTE) [deep vein thrombosis (DVT), pulmonary embolism (PE)] in patients with previous HIT who cannot use rivaroxaban Duration: 1 month if patient is able to transition to warfarin OR up to 1 year for patients who cannot be managed on warfarin* * Patients may not be able to use warfarin as extended treatment or prophylaxis of VTE due to contraindication, previous clinical failure, inability to swallow/ take oral medications, immobility, inability to monitor INR, etc. The reasons why warfarin is not appropriate must be clearly described. Renewal of funding for the above indications may be considered on a case-by-case basis with documented clinical rationale that includes details pertaining to patient’s risks for recurrent VTE, risks of bleeding, update on whether warfarin therapy may now be considered, and response to therapy. For peri-operative bridging for patients with history of HIT who require long-term warfarin therapy and must temporarily discontinue it before and after surgery, and who are at moderate- to high-risk for an embolic event while off warfarin. Duration: As requested up to a maximum of 10 days before the date of surgery plus up to 7 days after surgery Renewal of funding will NOT be considered for this indication. EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 29, record 9, corpus 2025-01-01; name match only, not an eligibility decision

Fondaparinux Sodium Injection · DIN 02406896 Manufacturer: Dr. Reddy's Laboratories Inc.; listing date 2014-07-30 Health Canada: Marketed since 2014-03-21 · brand FONDAPARINUX SODIUM INJECTION · ATC B01AX05 FONDAPARINUX · form Solution · route Subcutaneous · ingredients FONDAPARINUX SODIUM 7.5 MG/0.6ML · company Dr reddy's laboratories ltd · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02406896). DIN 02406896: Fondaparinux Sodium Injection Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 201200080; group id 257; item number 0498; lccId None; manufacturer id DRR Source form: Inj Sol-Pref Syr 0.6mL Pk (Preservative Free); strength: 7.5mg/0.6mL Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $18.1356; ministry $18.1356 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02406896 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=89156

Interchangeable products

Arixtra · DIN 02258056 · not recorded

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02406896

Shortage record checked 2026-09-13T08:10:21.292534+00:00