ACTEMRA*
Manufacturer DetailsGENETECH INC
Compositions:
Tocilizumab- mg,
Tocilizumab- mg,
| Strength | Rate | Packing Style |
|---|---|---|
| mg | 0.00 | unit |
List of Related Indications:
- Treatment for reducing signs and symptoms in adult patients with moderately severe rheumatoid arthiritis
List Of Drugs:
- Tocilizumab- Actemra -@- Musculo-skeletal (Jan 2010)
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
1 Other Drugs for Treatment of Rheumatoid Arthritis
Population pharmacokinetic analyses did not detect any effect of methotrexate
(MTX), non-steroidal anti-inflammatory drugs or corticosteroids on tocilizumab clearance.
Concomitant administration of a single intravenous dose of 10 mg per kg ACTEMRA with
10-25 mg MTX once weekly had no clinically significant effect on MTX exposure.
2.Exercise caution when coadministering ACTEMRA with CYP3A4 substrate drugs
where decrease in effectiveness is undesirable, e.g.,oral contraceptives, lovastatin,
atorvastatin, etc.
3.The effect of tocilizumab on CYP450 enzyme activity may persist for several weeks
after stopping therapy [see Clinical Pharmacology (12.3)].
4. Live Vaccines
Avoid use of live vaccines concurrently with ACTEMRA
Indication:
Proprietary Name- Actemra
Established Name - Tocilizumab
Applicant- Genetech
Indication-
Provides treatment for reducing signs and symptoms in adult
patients with moderately severely active Rheumatoid arthiritis
Approved by FDA on 8-1-2010 (Ref- FDA approved List- 2010)
Adverse Reaction:
Most common adverse reactions (incidence of at least 5%):
upper respiratory tract infections, nasopharyngitis, headache,
hypertension, increased ALT, injection site reactions.
Contra-Indications:
CONTRAINDICATIONS
ACTEMRA is contraindicated in patients with known hypersensitivity to ACTEMRA.
WARNING AND PRECAUTIONS
RISK OF SERIOUS INFECTIONS
Serious infections leading to hospitalization or death including tuberculosis (TB),
bacterial, invasive fungal, viral, and other opportunistic infections have occurred
in patients receiving ACTEMRA.
If a serious infection develops, interrupt ACTEMRA until the infection is controlled.
Perform test for latent TB; if positive, start treatment for TB prior to starting ACTEMRA.
Monitor all patients for active TB during treatment, even if initial latent TB test is negative.
Serious Infections do not administer ACTEMRA during an active infection,
including localized infections.
If a serious infection develops, Interrupt ACTEMRA until the infection is controlled.
Gastrointestinal (GI) perforation use with caution in patients who may be at
increased risk.
Laboratory monitoring,recommended due to potential consequences
of treatment-related changes in neutrophils, platelets, lipids, and liver function tests.
Hypersensitivity reactions, including anaphylaxis and death have occurred.
Live vaccines -Avoid use with ACTEMRA.
Dosages/ Overdosage Etc:
Indication-
Provides treatment for reducing signs and symptoms in adult
patients with moderately severely active Rheumatoid arthiritis
INDICATIONS AND USAGE
ACTEMRAR (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist
indicated for treatment of:
Rheumatoid Arthritis (RA)
Adult patients with moderately to severely active rheumatoid arthritis
who have had an inadequate response to one or more Disease-
Modifying Anti-Rheumatic Drugs (DMARDs).
Polyarticular Juvenile Idiopathic Arthritis (PJIA)
Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.
Systemic Juvenile Idiopathic Arthritis (SJIA)
Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.
DOSAGE AND ADMINISTRATION
ACTEMRA may be used alone or in combination with methotrexate: and in RA,
other DMARDs may be used.
Rheumatoid Arthritis
Recommended Adult Intravenous (IV) Dosage:
When used in combination with DMARDs or as monotherapy the recommended
starting dose is 4 mg per kg every 4 weeks followed by
an increase to 8 mg per kg every 4 weeks based on clinical response
General Dosing Information
It is recommended that ACTEMRA not be initiated in patients with an absolute
neutrophil count (ANC) below 2000 per mm3, platelet count below 100,000 per mm3,
or who have ALT or AST above 1.5 times the upper limit of normal (ULN).
ACTEMRA doses exceeding 800 mg per infusion are not recommended in RA patients.
Administration of Intravenous formulation
For adults, PJIA and SJIA patients at or above 30 kg, dilute to 100 mL
in 0.9% Sodium Chloride for intravenous infusion using aseptic technique.
For PJIA and SJIA patients less than 30 kg, dilute to 50 mL
in 0.9% Sodium Chloride for intravenous infusion using aseptic technique.
Administer as a single intravenous drip infusion over 1 hour; do not administer as
bolus or push.
Administration of Subcutaneous formulation
Follow the Instructions for Use for prefilled syringe
Dose Modifications
Recommended for management of certain dose-related laboratory changes
including elevated liver enzymes, neutropenia, and thrombocytopenia.
DOSAGE FORMS AND STRENGTHS
Single- use vials of ACTEMRA (20 mg per mL) for intravenous
administration:
80 mg per 4 mL
200 mg per 10 mL
400 mg per 20 mL
Prefilled Syringe (PFS) for subcutaneous administration:
A single use PFS providing 162 mg of ACTEMRA in 0.9mL
Patient Information:
PATIENT COUNSELING INFORMATION
Patient Counseling
Advise patients and parents or guardians of minors with PJIA or SJIA of the potential
benefits and risks of ACTEMRA. Physicians should instruct their patients to read
the Medication Guide before starting ACTEMRA therapy.
Infections:
Inform patients that ACTEMRA may lower their resistance to infections.
Instruct the patient of the importance of contacting their doctor immediately
when symptoms suggesting infection appear in order to assure rapid evaluation
and appropriate treatment.
Gastrointestinal Perforation:
Inform patients that some patients who have been treated with ACTEMRA have had
serious side effects in the stomach and intestines.
Instruct the patient of the importance of contacting their doctor immediately when
symptoms of severe, persistent abdominal pain appear to assure rapid evaluation
and appropriate treatment.
Hypersensitivity and Serious Allergic Reactions
Assess patient suitability for home use for SC injection.
Inform patients that some patients who have been treated with ACTEMRA
have developed serious allergic reactions, including anaphylaxis.
Advise patients to seek immediate medical attention if they experience any
symptom of serious allergic reactions.
Instruction on Injection Technique
Perform the first injection under the supervision of a qualified healthcare professional.
If a patient or caregiver is to administer subcutaneous ACTEMRA,
instruct him/her in injection techniques and assess his/her ability to inject
subcutaneously to ensure proper administration of subcutaneous ACTEMRA
and the suitability for home use [See Patient Instructions for Use].
Prior to use, remove the prefilled syringe from the refrigerator and allow to sit at room
temperature outside of the carton for 30 minutes, out of the reach of children.
Do not warm ACTEMRA in any other way.
Advise patients to consult their healthcare provider if the full dose is not received.
A puncture-resistant container for disposal of needles and syringes should be used
and should be kept out of the reach of children. Instruct patients or caregivers in
the technique as well as proper syringe and needle disposal, and caution against
reuse of these items.
Pharmacology/ Pharmacokinetics:
1. Mechanism of Action
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. IL-6 is a pleiotropic
pro-inflammatory cytokine produced by a variety of cell types including
T- and B-cells, lymphocytes, monocytes and fibroblasts.
2. Pharmacokinetics
Rheumatoid Arthritis¡XIntravenous Administration
The pharmacokinetics characterized in healthy subjects and RA patients suggested
that PK is similar between the two populations. The clearance (CL) of tocilizumab
decreased with increased doses. At the 10 mg per kg single dose in RA patients,
mean CL was 0.29 „b 0.10 mL per hr per kg and mean apparent terminal t1/2
was 151 „b 59 hours (6.3 days).
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1 Pregnancy
Pregnancy Category C.
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women
exposed to ACTEMRA during pregnancy. Physicians are encouraged to register patients
and pregnant women are encouraged to register themselves.
2. Nursing Mothers
Because many drugs are excreted in human milk, and because of the potential
for serious adverse reactions in nursing infants from ACTEMRA,a decision should
be made whether to discontinue nursing or to discontinue the drug, taking into
account the importance of the drug to the mother
3. Pediatric Use
Safety and effectiveness of ACTEMRA in pediatric patients with conditions other than
PJIA or SJIA have not been established. Children under the age of two have not been
studied. SC administration has not been studied in pediatric patients.
4. Geriatric Use
Clinical Studies , conducted revealed that the frequency of serious infection
among ACTEMRA treated subjects 65 years of age and older was higher than
those under the age of 65. As there is a higher incidence of infections in the elderly
population in general, caution should be used when treating the elderly
