Table 2.
Summary of oral disease modifying therapy for POMS.
| Fingolimod | |
| Mechanism of Action | Sphingosine 1 phosphate receptor modulator |
| Dosing | 0.25 or 0.5 mg by mouth once a day |
| Side effects | Headache |
| Back pain | |
| Diarrhea cough | |
| AE | Low ALC |
| QTc prolongation | |
| Respiratory Infection | |
| High ALT | |
| Rebound disease activity | |
| Rare PML | |
| Bradycardia | |
| First- and second-degree block | |
| Rebound disease sinusitis back pain first-dose monitoring requirement, contraindications in heart disease, risk of macular edema skin cancers | |
| Monitoring | contraindications in heart disease |
| VZV serum titer, pre FDO | |
| OCT pre and 3 months post FDO use with caution with other medications that prolong QTc interval | |
| Requires FDO < 6 h of observation with first dose with hourly vitals | |
| EKG before and after FDO | |
| CBC with diff baseline, 3 months then every 6 months | |
| JC index | |
| Avoid live vaccines while on Fingolimod and for 2 months after it is stopped. | |
| Pregnancy test prior to use, it is not recommended to get pregnant or nurse while on this product | |
| POMS publications | [9] |
| POMS RCT | Completed [2] |
| FDA approved in POMS | Approved in POMS 2018 |
| Dimethyl Fumarate | |
| Mechanism of Action | Increase Nuclear factor erythroid 2 (NF-E2)-related factor 2 |
| Dosing | 120 mg oral twice a day × 7 days then 240 mg oral twice a day |
| Side effects | Flushing, diarrhea, nausea, vomiting, and abdominal pain |
| Adverse events | Low absolute lymphocyte count |
| Rare PML case | |
| Monitoring | Baseline CBC with diff and LFT then q 12 months |
| Pregnancy test prior to use, it is not recommended to get pregnant or nurse while on this product | |
| POMS publications | [25] |
| POMS RCT | Yes, ongoing BG00012, ClinicalTrials.gov Identifier: NCT02283853 |
| ClinicalTrials.gov Identifier: NCT03870763 | |
| FDA approved for POMS | No |
| Teriflunomide | |
| Mechanism of Action | Inhibits pyrimidine biosynthesis |
| Dosing | 7 mg or 14 mg oral once a day |
| Side effects | Diarrhea |
| Nausea | |
| Headache | |
| Adverse events | Decreased hair density |
| Elevated Alanine aminotransferase | |
| Increased blood pressure | |
| Paresthesia in the upper extremities | |
| Major birth defects and embyrolethality in animal studies relatively long half-life of approximately 19 days, elimination can take >8 months | |
| Monitoring | CBC with diff, LFT baseline, LFT q month × 6, Blood pressure monitoring |
| Effective birth control compliance in male and female patients | |
| Contraindicated in severe hepatic impairment and those of child bearing potential not using effective birth control (http://products.sanofi.us/aubagio/aubagio.pdf) | |
| Pregnancy test prior to use, it is not recommended to get pregnant or nurse while on this product | |
| Rapid elimination due to long half life | If drug-induced liver injury or pregnancy is suspected, discontinue AUBAGIO and start an accelerated elimination procedure with cholestyramine or activated charcoal |
| POMS Publications | None |
| POMS RCT | Yes, ongoing ClinicalTrials.gov Identifier: NCT02201108 |
| FDA approved for POMS | None |
Abbreviations: ALC = absolute lymphocyte count, FDO = First dose observation, LFT = liver function tests, VZV = Varicella Zoster virus, PML = progressive multifocal leukoencephalopathy.