Drug Interaction:
No formal clinical drug interaction studies have been performed.
Subgroup analyses indicated that the concurrent use of bisphosphonates or
calcium channel blockers did not affect the safety and efficacy of Xofigo in
the randomized clinical trial.
Indication:
Xofigo (radium Ra 223 dichloride) Injection, for intravenous use
Initial U.S. Approval: 2013
Drug Name- Xofigo
Active Ingredient - Radium Ra 223 dichloride
To treat men with symptomatic late-stage(metastatic) castration-resistent prostrate
cancer that has spread to bones but not to other organs
Indication-
Metastatic castration- resitant prostrate cancer
Approved by FDA on 15-5-2013 (Ref- FDA approved List- 2013)
Proprietary Name- XOFIGO INJECTION*
Established Name- RAadium Ra223 Dichloride
Applicant- BAYER HEALTHCARE PHARMACEUTICALS INC.
Indication- Castration resistent prostrate cancer , symptomatic bone
metastases and no known visceral metastatic disease.
Xofigo is an alpha-particle emitiing radiotherapeutic
drug which mimics calcium and forms complexes with
hydroxyapitite at areas of increased bone turnover,
such as bone metastaes
Approval Date- May 15,2013
Approved by US FDA (Ref- FDA approved list- 2013)
Adverse Reaction:
The most common adverse drug reactions (. 10%) in patients receiving Xofigo
were nausea, diarrhea, vomiting, and peripheral edema.
The most common hematologic laboratory abnormalities ( 10%) were anemia,
lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia
Contra-Indications:
CONTRAINDICATIONS
Pregnancy
WARNINGS AND PRECAUTIONS
Bone Marrow Suppression: Measure blood counts prior to treatment
initiation and before every dose of Xofigo. Discontinue Xofigo
if hematologic values do not recover within 6 to 8 weeks after treatment.
Monitor patients with compromised bone marrow reserve closely.
Discontinue Xofigo in patients who experience life-threatening complications
despite supportive care measures.
Dosages/ Overdosage Etc:
Indication-
Metastatic castration- resitant prostrate cancer
INDICATIONS AND USAGE
Xofigo is an alpha particle-emitting radioactive therapeutic agent indicated
for the treatment of patients with castration-resistant prostate cancer,
symptomatic bone metastases and no known visceral metastatic disease.
DOSAGE AND ADMINISTRATION
The dose regimen of Xofigo is 50 kBq (1.35 microcurie) per kg body weight,
given at 4 week intervals for 6 injections.
DOSAGE FORMS AND STRENGTHS
Single- use vial at a concentration of 1,000 kBq/mL (27 microcurie/mL)
at the reference date with a total radioactivity of 6,000 kBq/vial
(162 microcurie/vial) at the reference date
Patient Information:
PATIENT COUNSELING INFORMATION
Advise patients:
To be compliant with blood cell count monitoring appointments while receiving
Xofigo. Explain the importance of routine blood cell counts. Instruct patients
to report signs of bleeding or infections.
To stay well hydrated and to monitor oral intake, fluid status, and urine output
while being treated with Xofigo. Instruct patients to report signs of dehydration,
hypovolemia, urinary retention, or renal failure / insufficiency.
There are no restrictions regarding contact with other people after receiving
Xofigo. Follow good hygiene practices while receiving Xofigo and for at least
1 week after the last injection in order to minimize radiation exposure from
bodily fluids to household members and caregivers.
Whenever possible, patients should use a toilet and the toilet should be
flushed several times after each use. Clothing soiled with patient fecal
matter or urine should be washed promptly and separately from other clothing.
Caregivers should use universal precautions for patient care such as gloves
and barrier gowns when handling bodily fluids to avoid contamination.
When handling bodily fluids, wearing gloves and hand washing will
protect caregivers.
Who are sexually active to use condoms and their female partners of
reproductive potential to use a highly effective method of birth control
during treatment and for 6 months following completion of Xofigo treatment.
:
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
The active moiety of Xofigo is the alpha particle-emitting isotope radium-223
(as radium Ra 223 dichloride), which mimics calcium and forms complexes
with the bone mineral hydroxyapatite at areas of increased bone turnover,
such as bone metastases.
2. Pharmacokinetics
The pharmacokinetics of radium-223 dichloride in blood was linear in terms of
dose proportionality and time independence in the dose range investigated
(46 to 250 kBq [1.24 to 6.76 microcurie] per kg body weight).
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Category X
Xofigo can cause fetal harm when administered to a pregnant woman based
on its mechanism of action. While there are no human or animal data on
the use of Xofigo in pregnancy and Xofigo is not indicated for use in women
maternal use of a radioactive therapeutic agent could affect development
of a fetus.
Xofigo is contraindicated in women who are or may become pregnant
while receiving the drug. If this drug is used during pregnancy, or if the patient
becomes pregnant while taking this drug, apprise the patient of the potential
hazard to the fetus and the potential risk for pregnancy loss.
Advise females of reproductive potential to avoid becoming pregnant during
treatment with Xofigo.
2. Nursing Mothers
Xofigo is not indicated for use in women. It is not known whether radium-223
dichloride is excreted in human milk.
Because many drugs are excreted in human milk, and because of potential
for serious adverse reactions in nursing infants from Xofigo, a decision
should be made whether to discontinue nursing, or discontinue the drug
taking into account the importance of the drug to the mother.
3. Pediatric Use
The safety and efficacy of Xofigo in pediatric patients have not been established.
4. Geriatric Use
Of the 600 patients treated with Xofigo in the randomized trial, 75% were 65 years
of age and over and while 33% were 75 years of age and over.
No dosage adjustment is considered necessary in elderly patients.
No overall differences in safety or effectiveness were observed between
these subjects and younger subjects, and other reported clinical experience
has not identified differences in responses between the elderly and younger
patients, but greater sensitivity of some older individuals cannot be ruled out.
Manufacturer Details