Adverse Effects/ Boxed Warning

BOXED WARNING: serious infections and malignancy

TNF Inhibitors (biologic)

• Risk of infections (UTI, URTI) and malignancies

• Demyelinating disorders

• Rash

• Injection/Infusion site reactions

• GI intolerance

• Worsening heart failure

TNF Inhibitors (biologic)

BOXED WARNING: Infections, malignancies, major adverse cardiovascular events, thrombosis, mortality (in patients with CV risk actors)

• Discontinue JAK inhibitors in patients with myocardial infarction or stroke

JAK inhibitors

• Hepatotoxicity

• GI perforation

• Blood cell disorders

• N/V/D, headache

JAK inhibitors

BOXED WARNING: Infections, malignancies, nephrotoxicity, only for use by physicians experienced in immunosuppressive therapy (for SOT), mortality in liver transplantation; (Astagraf XL) Nephrotoxicity; cyclosporine risk of malignancy with UVA light

Calcineurin Inhibitors (non-topicals)

• Neurotoxicity (tremor, headache, peripheral neuropathy, seizure)

• Electrolyte abnormalities (hyperkalemia, hypomagnesemia)

• QT prolongation

• Hypertension (more with cyclosporine)

• Hyperlipidemia (more with cyclosporine)

• Hyperglycemia (more with tacrolimus)

• Hirsutism (cyclosporine)

• Gingival hyperplasia (cyclosporine)

• Alopecia (tacrolimus)

Calcineurin Inhibitors (non-topicals)

BOXED WARNING: Malignancy, do not use in under 2 years of age

Calcineurin Inhibitors (topical)

• Burning, redness, itching

• Flu-like symptoms

Calcineurin Inhibitors (topical)

BOXED WARNINGS: infusion reactions, mucocutaneous

reactions, Hep B reactivation, PML

Anti-CD20 (Rituximab only)

• Infusion reactions

• URTI

• Serious infections

• Blood cell disorders

• Cardiovascular events

Anti-CD20

• Risk of serious infections

• Nasopharyngitis

• Skin cancer risk

L-23/IL-12 Inhibitor

• Risk of serious infections (typically URTI)

• Elevated LFTs

IL-23 Inhibitor

• Increased appetite

• insomnia

• Indigestion (bitter taste)

• Mood changes

• Headache

• Impaired wound healing

systemic steroids (common)

• Cataracts

• Hyperglycemia

• Hirsutism

• Acne

• Sodium/water retention

• Hypertension

• Weight gain

• Bone growth suppression

• Ulcerative esophagitis, PUD

systemic steroids (chronic)

BOXED WARNING: Progressive multifocal leukoencephalopathy (PML)

Integrin Inhibitors (Natalizumab only)

• Depression (natalizumab only)

• Risk of infections

• Nasopharyngitis

• Elevated liver enzymes

• Infusion-related reactions

Integrin Inhibitors

BOXED WARNINGS: serious adverse effects involving bone marrow, GI tract, liver, lungs, skin, and kidneys; contraindicated in pregnancy and in hypersensitivity

Methotrexate (Trexall)

• N/V, elevated LFTs

• Increased risk of infections

Methotrexate (Trexall)

• N/V (often severe)

• Diarrhea

• Alopecia

• Hematologic toxicities

• Increased risk of infections

• Liver dysfunction

• Pancreatitis

• Sun sensitivity

Azathioprine

BOXED WARNING: malignancy

Azathioprine

• Retinopathy

• N/V/D

• Headache

• Constipation

• Rare:

  • QT prolongation

  • Psychosis

  • Myopathy

Hydroxychloroquine (Plaquenil)

BOXED WARNINGS: serious infections, malignancies, embryo-fetal toxicity

Mycophenolate mofetil (CellCept), Mycophenolate sodium-enteric coated (Myfortic)

• GI: N/V/D, abdominal pain, heartburn, bloating

• Leukopenia, anemia

• PML and pure red cell aplasia

Mycophenolate mofetil (CellCept), Mycophenolate sodium-enteric coated (Myfortic)

BOXED WARNING: autoimmunity, infusions reaction, stroke, and

malignancy

Anti-CD52

• Infusion reactions (nearly all patients)

• Hematologic effects

• Headache

• Fatigue

• Nausea/Vomiting/Diarrhea

• Increased risk for infection

• Thyroid dysfunction

Anti-CD52

• URTI

• Varicella zoster infection

• AV block, bradycardia

• Increased BP

• Hepatotoxicity

• Lymphopenia

• Macular edema

• Neurotoxicity and PML

• Decreased pulmonary functio

S1P Receptor Modulator

• N/V

• Headache

• Delayed hypersensitivity

• Nephrotoxicity (rare)

Aminosalicylate

• Depression

• Injection site reactions

• Flu-like symptoms

• Leukopenia

• Increased LFTs

• Thyroid dysfunction

Beta Interferons

• Flushing

• GI disturbances

• Neutropenia

• Hepatotoxicity

Fumarates

BOXED WARNING: anaphylaxis can occur at any time during treatment

Myelin “decoy”

• Injection site reactions

• Risk of infections

• Lipoatrophy

• Chest tightness

• Flushing, diaphoresis, dyspnea

Myelin “decoy”

BOXED WARNING: hepatotoxicity and teratogenicity

Pyrimidine synthesis inhibitor

• Risk of infections

• Headache, diarrhea

Pyrimidine synthesis inhibitor

• Skin atrophy, acne-like reactions

• Withdrawal syndrome: itching, warmth, burning on topical site

• Potential systemic adverse effects with prolonged use

Topical Steroids

• Contact dermatitis

• Peeling

• Dryness

• Erythema

Vitamin D

• Risk of serious infections (fungal)

• Nasopharyngitis

IL-17 Inhibitor

• Infusion-related reactions

• Nausea, diarrhea

• Risk of infection

• Anxiety, depression, suicidal ideation

BLyS Inhibitor

• Hemorrhagic cystitis (manage with hydration and mesna)

• N/V

• Risk of infection

• Bone marrow suppression

• Toxicities: cardiac, hepatic, pulmonary

Cyclophosphamide