Pill Identifier App

Indium In 111 Capromab Pendetide (Systemic)


VA CLASSIFICATION
Primary: DX201

Commonly used brand name(s): ProstaScint.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Diagnostic aid, radioactive (prostatic disease)—

Indications

Accepted

Prostatic carcinoma, intra-pelvic metastases (diagnosis) and
Prostatic carcinoma, occult, recurrence (diagnosis)—Indium In 111 capromab pendetide is indicated for use in immunoscintigraphy in patients with biopsy-proven prostate carcinoma who are at high risk for pelvic lymph node metastases {01}. Indium In 111 capromab pendetide is also indicated in patients who have undergone a prostatectomy, and have rising prostate-specific antigen (PSA) values and equivocal or no evidence of metastatic disease on standard metastatic evaluation, but in whom there is a high clinical suspicion of occult metastatic disease {01}.
—In phase 3 clinical trials, high-risk patients were defined as having one of the following: PSA ³ 10 times the upper limit of normal and Gleason score ³ 7; prostatic acid phosphatase above the upper limit of normal; equivocal evidence of lymph node metastases on computed tomography (CT) or ultrasound and PSA ³ 8 times the upper limit of normal; Gleason score ³ 8; clinical stage C and Gleason score ³ 6 {01}.

Unaccepted
Not indicated as a screening test for carcinoma of the prostate or for readministration in order to assess response to treatment. {01}


Physical Properties

Nuclear data:

{01}

Radionuclide
(half-life)
Mode of
decay
Principal
photon
emissions
(keV)
Mean number
of emissions/
disintegration
In 111
(2.83 days)
Electron
capture
Gamma-2
(171.3)
0.90


    Gamma-3
(245.4)
0.94


Pharmacology/Pharmacokinetics

Mechanism of action/Effect:

Capromab (MAb 7E11-C5.3), a murine monoclonal antibody of the immunoglobulin subclass IgG 1K, localizes or binds specifically to a prostate-specific membrane glycoprotein (PSMA) that is only expressed by prostatic epithelial cells (benign and malignant) {01}. The monoclonal antibody 7E11-C5.3 is site-specifically labeled with indium In 111 chloride using the linker-chelator, glycyl-tyrosyl-(N,epsilon-diethylenetriaminepentaacetic acid)-lysine hydrochloride or GYK-DTPA-HCl {01}. The resultant radiolabeled monoclonal antibody conjugate, 111In capromab pendetide (CYT-356), retains the immunoreactivity of the unconjugated monoclonal antibody. Following intravenous administration, the indium In 111–labeled capromab pendetide travels through the blood stream until it encounters tumors bearing the specific antigen. The distribution of radioactivity is recorded by imaging {01}.

Distribution:

Following intravenous administration, indium In 111 capromab pendetide localizes to the prostate and some primary and metastatic tumor sites {01}. Some non–antigen-dependent localization occurs, probably secondary to catabolism, in normal liver, spleen, and bone marrow {01}. In some individuals, some radioactivity may localize in the bowel, blood pool, kidneys, urinary bladder, and genitalia {01}.

Half-life:


Elimination:

67 ± 11 hours (mean ± SD) {01}.


Radiation dosimetry:
{01}

Estimated absorbed radiation dose *
Organ
mGy/MBq
rad/mCi
Liver
1
3.7
Spleen
0.88
3.26
Kidneys
0.67
2.48
Prostate
0.44
1.64
Heart wall
0.42
1.56
Large intestine
wall (lower)

0.41

1.52
Gall bladder wall
0.39
1.46
Lungs
0.3
1.12
Testes
0.3
1.12
Adrenals
0.28
1.04
Pancreas
0.28
1.04
Large intestine
wall (upper)

0.27

1
Red marrow
0.23
0.86
Bone surfaces
0.22
0.8
Small intestine
0.18
0.66
Stomach
0.17
0.62
Thymus
0.14
0.52
Urinary bladder
wall

0.12

0.44
Other tissues
0.11
0.4
Thyroid
0.08
0.28
Brain
0.06
0.22
Skin
0.06
0.22
Total body
0.15
0.54
* For adults; intravenous injection {01}. Includes absorbed radiation doses from both the indium In 111 and the indium In 114m radiocontaminant. A level of 0.06% of indium In 114m was used for dose estimates {01}.

Elimination:
    Renal (10% of the administered activity excreted within 72 hours) {01}.


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to murine antibody–based products may be sensitive to indium In 111 capromab pendetide also {01}.

Carcinogenicity/Mutagenicity

Long-term animal studies to evaluate carcinogenic or mutagenic potential of indium In 111 capromab pendetide have not been performed {01}.

Pregnancy/Reproduction

Pregnancy—
Indium In 111 capromab pendetide is not indicated for use in women {01}.

Breast-feeding

Indium In 111 capromab pendetide is not indicated for use in women {01}.

Pediatrics

There have been no specific studies evaluating the safety and efficacy of indium In 111 capromab pendetide in pediatric patients {01}.


Geriatrics


Diagnostic studies performed to date using indium In 111 capromab pendetide have not demonstrated geriatrics-specific problems that would limit the usefulness of indium In 111 capromab pendetide in the elderly {01}.


Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With other diagnostic test results
Immunoassays, including those used to assay prostate-specific antigen (PSA) and digoxin{01}    (human anti-murine antibody [HAMA] production rarely may be induced by the administration of indium In 111 capromab pendetide; HAMA in serum may cause falsely elevated values of in vitro immunoassays {01}; interference may persist for months; use of non–murine-based immunoassays, or HAMA removal by adsorption, is recommended to avoid interference {01})

With physiology/laboratory test values
Bilirubin, serum{01}    (concentration may be increased {01})


Diagnostic interference
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With results of this test

Due to other medications
Murine antibody–based products{01}    (previous administration of murine antibody–based products, including this agent, may induce human anti-murine antibody [HAMA], which may alter the clearance and tissue biodistribution of indium In 111 capromab pendetide; however, more studies are needed to establish the effects of circulating HAMA on monoclonal antibody–based products {01})


Due to medical problems or conditions
Aneurysms, abdominal{01} or
Bowel adhesions, postoperative{01} or
Colostomy{01} or
Inflammatory lesions, local{01} or
Joint disease, degenerative{01}    (localization of indium In 111 capromab pendetide may occur at these sites {01})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problem exists
Sensitivity to murine antibody–based products or to the radiopharmaceutical preparation{01}


Side/Adverse Effects

Note: Allergic reactions, including anaphylaxis, can occur in patients receiving murine antibody-based products {01}. Although serious allergic reactions have not been reported during clinical trials with indium In 111 capromab pendetide, the possibility must be considered and proper treatment measures should be readily available {01}.

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence more frequent
    
Hypertension{01}
    
hypotension{01}



Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent or rare
    
Change in taste{01}
    
fever{01}
    
headache{01}
    
muscle weakness{01}
    
skin rash{01}





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Radiopharmaceuticals (Diagnostic)

In providing consultation, consider emphasizing the following selected information (» = major clinical significance)

Description of use
Action in the body: Localization at sites of tumor spread or growth

Tumor sites may be visualized by external imaging

Small amounts of radioactivity used in diagnosis; radiation received is low and considered safe

Before having this test
»   Conditions affecting use, especially:
Sensitivity to murine antibody–based products or to the radiopharmaceutical preparation

Preparation for this test
Special preparatory instructions may be given; patient should inquire in advance

Administering a laxative the evening before imaging, and an enema 1 hour before imaging to minimize imaging interference due to radioactivity localization in bowel {01}


Side/adverse effects
Signs of potential side effects, especially hypertension and hypotension


General Dosing Information
Radiopharmaceuticals are to be administered only by or under the supervision of physicians who have had extensive training in the safe use and handling of radioactive materials {01} and who are authorized by the Nuclear Regulatory Commission (NRC) or the appropriate Agreement State agency, if required, or, outside the U.S., the appropriate authority.

Unlabeled capromab pendetide should not be administered directly to the patient {01}.

Two SPECT (single photon emission computed tomography) imaging sessions are needed; the first, performed approximately 30 minutes after infusion of indium In 111 capromab pendetide, should be of the pelvis to obtain a blood pool image {01}. The second SPECT imaging session, performed between 72 and 120 hours after infusion of the agent for the detection of benign and malignant prostate tissue sites, should involve both the pelvis and abdomen, including the lower liver margin through the prostatic fossa {01}.

Laxative administration the evening prior to imaging is recommended to minimize radioactivity in the bowel, which may interfere with image interpretations {01}. A cleansing enema should be administered within 1 hour prior to each 72- to 120-hour imaging session {01}. Also, the bladder should be catheterized and irrigated {01}.

Safety considerations for handling this radiopharmaceutical
Guidelines for the receipt, storage, handling, dispensing, and disposal of radioactive materials are available from scientific, professional, state, federal, and international bodies. Handling of this radiopharmaceutical should be limited to those individuals who are appropriately qualified and authorized {01}.

For treatment of adverse effects
Epinephrine, antihistamines, and corticosteroid agents should be available during the administration of indium In 111 capromab pendetide because of the possibility of allergic reactions {01}.


Parenteral Dosage Forms

INDIUM In 111 CAPROMAB PENDETIDE INJECTION

Usual adult administered activity
For detection of the extent and localization of prostatic carcinoma—Intravenous infusion, 0.5 mg of capromab pendetide radiolabeled with 185 megabecquerels (5 millicuries) of indium In 111 chloride, administered as a single dose over a period of five minutes {01}.

Note: Indium In 111 capromab pendetide may be readministered following infiltration or a technically inadequate image {01}.


Usual pediatric administered activity
Safety and efficacy have not been established {01}.

Usual geriatric administered activity
See Usual adult administered activity .

Strength(s) usually available
U.S.—


0.5 mg of capromab pendetide per 1-mL single-dose vial of sodium phosphate–buffered saline solution (Rx) [ProstaScint]

Note: A 2-mL vial of sodium acetate buffer solution 0.5 M is also provided in the kit {01}.


Packaging and storage:
Before radiolabeling, store between 2 and 8 °C (36 and 46 °F), unless otherwise specified by manufacturer {01}.

Note: Product should be brought to room temperature before radiolabeling {01}.
After radiolabeling, injection may be kept at room temperature, up to 8 hours, until administration {01}.


Preparation of dosage form:
To prepare injection, a sterile, pyrogen-free indium In 111 chloride solution is used {01}. Isotope solution must be buffered with sodium acetate before adding to the capromab pendetide solution. See manufacturer's package insert for instructions {01}.

Stability:
Injection should be administered within 8 hours after radiolabeling. {01}

Note: Caution—Radioactive material.




Developed: 08/05/1997



References
  1. ProstaScint package insert (Cytogen—US), New 10/28/96, Rec 3/6/97.
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