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Tocilizumab; Uses, Dosage, Side Effects, Drug Interactions

Tocilizumab is an immunosuppressive drug, mainly for the treatment of rheumatoid arthritis (RA) and systemic juvenile idiopathic arthritis, a severe form of arthritis in children. It is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). Interleukin 6 (IL-6) is a cytokine that plays an important role in immune response and is implicated in the pathogenesis of many diseases, such as autoimmune diseases, multiple myeloma and prostate cancer.

Mechanism of action of Tocilizumab

Interleukin (IL)-6 plays essential roles not only in the immune response, but also in haematopoiesis and the central nervous system. Unregulated production of IL-6 has been found in chronic inflammatory autoimmune diseases, such as rheumatoid arthritis (RA), systemic onset juvenile idiopathic arthritis (soJIA), Crohn’s disease (CD), systemic lupus erythematosus (SLE) and vasculitis. Furthermore, IL-6 activities can explain many symptoms of these diseases. More importantly, serum levels of IL-6 are correlated with disease activity. Tocilizumab binds specifically to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and has been shown to inhibit IL-6-mediated signaling through these receptors.

Indications of Tocilizumab

Giant cell arteritis
Cytokine release syndrome
Juvenile idiopathic arthritis
Rheumatoid arthritis
Systemic sclerosis
Polyarticular juvenile idiopathic arthritis
Severe aplastic anemia
Systemic juvenile idiopathic arthritis
Refractory aplastic anemia

Contra Indication of Tocilizumab

Diabetes
High cholesterol
Low amount of magnesium in the blood
Low amount of phosphate in the blood
Low amount of calcium in the blood
Low amount of sodium in the blood
High amount of potassium in the blood
Low amount of potassium in the blood
Anemia
Decreased blood Platelets
Decreased neutrophils a type of white blood cell
High blood pressure
Very Rapid Heartbeat – torsades de Pointes
prolonged QT interval on EKG
Abnormal EKG with QT changes from Birth
Hardening of the arteries due to plaque buildup
Liver problems
High Amount of Bilirubin in the Blood
High Blood Sugar
Abnormal liver function tests
Pregnancy
A mother who is producing milk and breastfeeding
Relapse of Hepatitis B Infection Symptoms
Pancreatitis
past history of complete removal of stomach
Reduced UGT1A1 Enzyme Activity due to 28 Polymorphism
High Blood Levels of the Lipase Enzyme
High Blood Levels of the Amylase Enzyme

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Dosage of Tocilizumab

Strengths: 20 mg/mL; 162 mg/0.9 mL

Rheumatoid Arthritis

4 mg/kg IV as a 60-minute single drip infusion once every 4 weeks, followed by an increase to 8 mg/kg IV given once every 4 weeks as a 60-minute single drip infusion based on clinical response
Dose adjustment: Reduction from 8 mg/kg to 4 mg/kg is recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia.
Maximum dose: 800 mg per infusion

Subcutaneous

Patients less than 100 kg: 162 mg subcutaneously every other week, followed by an increase to every week based on clinical response
Patients 100 kg or greater: 162 mg subcutaneously every week
Dose adjustment: Interruption of dose or reduction in frequency of administration from every week to every other week is recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia.

Giant Cell Arteritis

162 mg subcutaneously once a week in combination with a tapering course of glucocorticoids
Dose adjustment: 162 mg subcutaneously every other week in combination with a tapering course of glucocorticoids may be appropriate based on clinical considerations

Pediatric Juvenile Idiopathic Arthritis

Polyarticular Juvenile Idiopathic Arthritis (PJIA)
2 years or older

Weight less than 30 kg: 10 mg/kg IV as a 60-minute single drip infusion

once every 4 weeks

Weight 30 kg or more: 8 mg/kg as a 60-minute single drip infusion

once every 4 weeks

Systemic Juvenile Idiopathic Arthritis (SJIA)

2 years or older

Weight less than 30 kg: 12 mg/kg IV as a 60-minute single drip infusion

Once every 2 weeks

Weight 30 kg or more: 8 mg/kg IV as a 60-minute single drip infusion

once every 2 weeks

Side Effects of Tocilizumab

The most common

chest pain
certainly hair loss
headache
joint painPain
dizziness
nausea and vomiting
Severe stomach ache
epigastric pain,
diarrhoea,
anorexia,
flatulence,
headache,
dizziness,
fainting, fast or pounding heartbeats.

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More common

Fast or irregular heartbeat
appetite loss
changes in nails
constipation
fatigue
fever
Back pain
dizziness
headache
increased cough
Acid or sour stomach
decreased appetite
Agitation
chest congestion
chest pain
cold sweats
confusion
decreased sexual ability or desire
stomach or abdominal cramps, gas, or pain
trouble sleeping

Less common

bleeding gums
blood in the urine or stools
chest pain
diarrhea
Burning, crawling, itching, numbness, prickling, “pins and needles“, or tingling feelings
difficulty in moving
muscle stiffness
redness of the face, neck, arms and occasionally, upper chest
lack or loss of strength
muscle spasm
difficult or labored breathing
dry mouth
headache
irritability
lack or loss of strength
loose stools
loss of interest or pleasure
muscle stiffness
night sweats
passing gas
stomach discomfort, upset, or pain
swollen joints
trouble concentrating
increased blood pressure

Drug Interactions of Tocilizumab

Nilotinib may interact with following drugs ,suppliments & may chane the efficacy of drug

alpha blockers (e.g., alfuzosin, doxazosin, silodosin, tamsulosin)
anticancer medications (e.g., cabazitaxel, docetaxel, doxorubicin, etoposide, ifosfamide, irinotecan, vincristine)
“azole” antifungal medications (e.g., fluconazole, itraconazole, ketoconazole)
beta-blockers (e.g., atenolol, propranolol, metoprolol)
barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
benzodiazepines (e.g., chlordiazepoxide, clonazepam, diazepam, lorazepam)
calcium channel blockers (e.g., nifedipine, diltiazem, verapamil, amlodipine, felodipine)
carbamazepine
chloroquine
corticosteroids (e.g., dexamethasone, prednisone, methylprednisolone)
cyclosporine
dantrolene
“gliptin” diabetes medications (e.g., linagliptin, saxagliptin, sitagliptin)
HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, efavirenz, etravirine, nevirapine)
HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
losartan
macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
metronidazole
mirtazapine
modafinil
montelukast
norfloxacin
ondansetron
carbamazepine
peginterferon alfa-2b
phenytoin
progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
proton pump inhibitors (PPIs; e.g., esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole)
selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine,paroxetine, sertraline)
sildenafil
“statin” anticholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)
tacrolimus
tadalafil
tamoxifen
tetracycline
theophylline
tocilizumab
tolterodine
tramadol
other selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, sertraline)
5-HT3 antagonists (e.g., granisetron, ondansetron)
tamsulosin
tapentadol
thiazide diuretics (e.g., hydrochlorothiazide, indapamide)
tramadol
tricyclic antidepressants (e.g., nortriptyline, amitriptyline, imipramine,
other tyrosine kinase inhibitors (e.g., dasatinib, imatinib, nilotinib, sunitinib)
tetracycline
tocilizumab
vandetanib
vemurafenib
trimethoprim
vaccines
warfarin

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Pregnancy & Lactation of Tocilizumab

FDA Pregnancy Category C

Pregnancy

This medication should not be used during pregnancy unless the benefits outweigh the risks. Effective birth control must be used to prevent pregnancy during treatment and for 3 months after the last dose of tocilizumab. If you become pregnant while receiving this medication, contact your doctor immediately.

Lactation

It is not known if tocilizumab passes into breast milk. If you are a breast-feeding mother and are receiving this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Tocilizumab