Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: SpringWorks Therapeutics Ireland Limited, Hamilton House, 28 Fitzwilliam Place, Dublin 2, D02 P283, Ireland
Ogsiveo as monotherapy is indicated for the treatment of adult patients with progressing desmoid tumours who require systemic treatment.
Ogsiveo should be initiated and monitored by a physician experienced in the use of anticancer therapies.
The recommended dose is 150 mg Ogsiveo twice daily, one dose in the morning and one dose in the evening. This dose should not be exceeded.
Ogsiveo should be continued until disease progression or unacceptable toxicity.
If a dose of Ogsiveo is missed, patients should not take an additional dose. Patients should take the next prescribed dose.
The recommended dose modifications for selected adverse reactions are provided in Table 1.
For other severe adverse reactions, or in the event of life‑threatening adverse reactions, Ogsiveo should be withheld until the reaction is resolved to Grade ≤ 1 or baseline. Ogsiveo should only be restarted at a dose of 100 mg twice daily and only after carefully considering the potential benefit and likelihood of recurrence of the adverse reaction. Ogsiveo should be permanently discontinued for recurrence of severe or life-threatening adverse reaction upon rechallenge at the reduced dose.
Dose modifications should be made if patients experience the following adverse reactions (grades refer to Common Terminology Criteria for Adverse Events):
Table 1. Recommended dose modifications for adverse reactions in patients treated with Ogsiveo:
| Adverse reaction | Recommended action |
|---|---|
| Diarrhoea | |
| Grade 3 diarrhoea persisting for ≥ 3 days despite maximal medical therapy | Ogsiveo should be withheld until reaction is resolved to Grade ≤ 1 or baseline, then it should be restarted at a dose of 100 mg twice daily. |
| Skin reactions | |
| Grade 3 folliculitis | Ogsiveo should be withheld until reaction is resolved to Grade ≤ 1 or baseline, then it should be restarted at a dose of 100 mg twice daily. |
| Grade 3 maculopapular rash | Ogsiveo should be withheld until reaction is resolved to Grade ≤ 1 or baseline, then it should be restarted at a dose of 100 mg twice daily. |
| Grade 3 hidradenitis | Ogsiveo should be withheld until reaction is resolved to Grade ≤ 1 or baseline, then it should be restarted at a dose of 100 mg twice daily. |
| Electrolyte abnormalities | |
| Grade 3 hypophosphataemia persisting for ≥ 7 days despite maximal replacement therapy | Ogsiveo should be withheld until reaction is resolved to Grade ≤ 1 or baseline, then it should be restarted at a dose of 100 mg twice daily. |
| Grade 3 hypokalaemia despite maximal replacement therapy | Ogsiveo should be withheld until reaction is resolved to Grade ≤ 1 or baseline, then it should be restarted at a dose of 100 mg twice daily. |
| Hepatic abnormalities | |
| Alanine transaminase (ALT) or Aspartate transaminase (AST) ≥ 3 to 5 x ULN | Ogsiveo should be withheld until ALT, AST, or both are resolved to < 3 x ULN or baseline, then it should be restarted at a dose of 100 mg twice daily. |
| ALT or AST > 5 x ULN | Ogsiveo should be permanently discontinued. |
| Other adverse reactions | |
| Anaphylaxis or other severe hypersensitivity reaction | Ogsiveo should be permanently discontinued. |
No dose adjustment is recommended for patients who are aged 65 years or over. Clinical data in patients aged 65 years or over is limited.
No dose adjustment is recommended in patients with mild or moderate renal impairment. Administration is not recommended in patients with severe renal impairment (see section 5.2).
No dose adjustment is recommended in patients with mild or moderate hepatic impairment. Administration is not recommended in patients with severe hepatic impairment (see section 5.2).
The safety and efficacy of Ogsiveo in children from 2 to 18 years of age have not been established. Ogsiveo should not be used in children from birth to less than 2 years of age because of potential safety concerns related to structural and functional growth. Currently available data are described in sections 4.8 and 5.1, but no recommendation on a posology can be made.
Ogsiveo is for oral use.
The tablets may be taken with or without food. Tablets should not be broken, chewed or crushed because there are no data currently available to support other methods of administration.
Patients should avoid consuming grapefruit and grapefruit juice while taking Ogsiveo (see section 4.5).
The symptoms of Ogsiveo overdose are expected to be an extension of its pharmacological actions and may include diarrhoea, nausea, vomiting, hypophosphataemia, elevated transaminases, and epistaxis.
Due to the high level of protein binding, Ogsiveo is not expected to be dialyzable in patients with normal serum protein levels. In the event of an overdosage, treatment with Ogsiveo should be stopped and general supportive measures should be initiated.
2 years.
Store below 25°C.
Ogsiveo 50 mg film‑coated tablets:
HDPE bottle with child resistant closure and induction seal containing 120 or 180 tablets.
Ogsiveo 100 mg film‑coated tablets
Ogsiveo 150 mg film‑coated tablets:
Clear PVC/PVDC blisters with aluminium lidding containing 14 tablets. One pack contains 56 tablets in 4 blisters.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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