MSB (ASX) Ann: Long-Term Survival for Acute GvHD Treatment with Remestemcel

Originally posted by dachopper ↑

ivermectin the safest drug in world history? I don't think MSC's have almost any of these side effects
General

Ivermectin is well tolerated compared to other microfilaricidal agents (i.e., thiabendazole, diethylcarbamazine). Adverse reactions (i.e., pruritus, fever, rash, myalgia, headache) occur commonly during the first 3 days after treatment and appear to be related to the extent of parasitic infection and systemic mobilization and killing of microfilariae. The majority of reactions can usually be treated with aspirin, acetaminophen and/or antihistamines. Adverse effects tend to occur with lesser frequency during periods of retreatment.[Ref]
Ocular

Ocular side effects have included eyelid edema, anterior uveitis, blurred vision, conjunctivitis, limbitis, punctate opacity, keratitis, abnormal sensation in the eyes, and chorioretinitis/choroiditis; however, these effects are also associated with the disease onchocerciasis. Loss of vision has occurred rarely but usually resolved without corticosteroid treatment. Conjunctival hemorrhage has been reported during postmarketing experience in patients treated for onchocerciasis.[Ref]
Other

Worsening of Mazzotti reactions, including arthralgia, synovitis, lymph node enlargement and tenderness, pruritus, skin involvement (including edema, papular and pustular or frank urticarial rash), and fever, has been reported during the first 4 days following treatment for onchocerciasis.
Nervous system

Nervous system side effects have included dizziness, headache, somnolence, vertigo, and tremor. Serious or fatal encephalopathy has been reported rarely in patients with onchocerciases, and heavily infected with Loa loa, either spontaneously or after treatment with ivermectin. Seizures have been reported during postmarketing experience.[Ref]
Gastrointestinal

Gastrointestinal side effects have included anorexia, constipation, diarrhea, nausea, vomiting, and abdominal distention.[Ref]

Other

Other side effects have included asthenia, fatigue, abdominal pain, chest discomfort, facial edema, and peripheral edema.
Hematologic

Hematologic side effects have included decreased leukocyte count (3%), eosinophilia (3%), and increased hemoglobin (1%). Hematomatous swellings associated with prolonged prothrombin times have been reported, but the clinical significance is unknown. Leukopenia and anemia have been reported in at least one patient.[Ref]
Hepatic

Hepatic side effects have included elevated ALT and/or AST. Elevated liver enzymes, elevated bilirubin, and hepatitis have been reported during postmarketing experience.[Ref]
Cardiovascular

Cardiovascular side effects have included tachycardia and orthostatic hypotension. EKG changes, including prolonged PR interval, flattened T waves and peaked T waves, have been reported in single cases. Hypotension (primarily orthostatic hypotension) has been reported during postmarketing experience.[Ref]
Dermatologic

Dermatologic side effects have included pruritus, rash, and urticaria. Toxic epidermal necrolysis and Stevens-Johnson syndrome have been reported during postmarketing experience.
Respiratory

Respiratory side effects have included worsening bronchial asthma, laryngeal edema, and dyspnea.[Ref]
Musculoskeletal

Musculoskeletal side effects have included myalgia.
Renal

Renal side effects have included rare transient proteinuria.[Ref]

Expand

Unfortunately Novartis was unable to find any evidence of beneficial clinical efficacy associated with Remestemcel treatment either...

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Ann: Long-Term Survival for Acute GvHD Treatment with Remestemcel, page-303

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