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Guide
Drug Safety-related Labeling Changes (SrLC) Database
| ANDA | Abbreviated New Drug Application |
| BLA | Biologics License Application |
| CDER | Center for Drug Evaluation and Research |
| MG | Medication Guide |
| NDA | New Drug Application |
| PCI | Patient Counseling Information |
| PI | Patient Information |
| PLR | Physician Labeling Rule |
| PLLR | Pregnancy and Lactation Labeling Rule |
| Italics | For the most part, italics indicate an FDA comment such as:
Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section. |
| Underlines | Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text. |
Sections
| BW | Box Warning |
| WP | Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format) |
| AR | Adverse Reactions (in pre-PLR format, this may be a subheading under precautions). |
| DI | Drug Interactions (in pre-PLR format, this may be a subheading under precautions). |
| USP | Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format. |
| PCI/PI/MG | Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. |
Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.
Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.
HICON (NDA-021305)
(SODIUM IODIDE I-131)
Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)
06/11/2021 (SUPPL-47)
4 Contraindications
(Additions and/or revisions underlined)
HICON is contraindicated in:
Patients with vomiting and diarrhea [see Warning and Precautions (5.7)].
Patients with thyroid malignancies shown to have no iodide uptake, which include the majority of medullary or anaplastic carcinomas.
Patients receiving concurrent anti-thyroid therapy [see Warning and Precautions (5.1) and Drug Interactions (7)].
Pregnancy [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)].
5 Warnings and Precautions
5.1 Radiation-induced Thyroiditis(Newly added subsection)
Sodium iodide I 131 may cause thyroiditis with gland enlargement and release of thyroid hormone, which may cause or aggravate hyperthyroidism, thyroid storm and thyrotoxic cardiac disease [see Adverse Reactions (6)]. When treating hyperthyroidism, consider pre-treatment anti-thyroid medication to help deplete the thyroid hormone content within the gland. Discontinue the anti-thyroid medication at least three days before administration of sodium iodide I 131 [see Drug Interactions (7)]. Consider a beta-blocker pre or post-treatment to minimize the risk of hyperthyroidism and thyroid storm.
Thyroiditis may cause gland enlargement resulting in tenderness and swelling of the neck, pain on swallowing, sore throat, and cough; which may occur approximately the third day after sodium iodide I 131 administration. Consider management with pain-reliever or anti- inflammatory medications.
(Subsection title revised; Additions and/or revisions underlined)
Sodium Iodide I 131 may cause radiation induced toxicities [see Adverse Reactions (6)]:
- Dose-dependent fatalities (bone marrow suppression, malignancy).
- Dose-dependent hematopoietic suppression which manifests as a transient thrombocytopenia or neutropenia 3 to 5 weeks following sodium iodide I 131 administrations, may lead to increased susceptibility to infections or bleeding.
- Salivary gland toxicity: sialadenitis, xerostomia.
- Lacrimal gland toxicity: conjunctivitis, xerophthalmia, and epiphora.
- Increased risk of developing new solid tumors and leukemias.
Obtain a complete blood count within one month of therapy. If patients show leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity, while delivering less than 2 Gy to the bone marrow.
Advise good hydration for one week following sodium iodide I 131 administration and stimulate salivary flow via a sialagogue (e.g. sugar-free candy or gum, pilocarpine, and ascorbic acid) to reduce radiation exposure to the salivary glands.
Advise patients to void frequently after administration of radioiodide to enhance excretion.
(Subsection title revised; Additions and/or revisions underlined)
HICON is contraindicated in pregnancy because sodium iodide I 131 crosses the placenta and fetal exposure can lead to neonatal hypothyroidism. Multiple reports in the published literature describe hypothyroidism in the neonates following in utero exposure to sodium iodide I 131. Some cases of neonatal hypothyroidism were severe and irreversible. Verify pregnancy status of females of reproductive potential prior to initiating HICON treatment. Advise females and males of reproductive potential to use effective contraception during treatment with HICON and for at least 6 months after the last dose [see Use in Specific Populations (8.1, 8.3)].
(Newly added subsection)
HICON is contraindicated in lactating women because sodium iodide I 131 concentrates in the breast via the increased expression of the sodium iodide symporter in breast tissue with lactation. The literature describes moderate to marked radioiodine uptake in the breast tissue for 5 to 32 weeks post cessation of breast feeding. Advise lactating women to discontinue breast feeding at least 6 weeks prior to administration of sodium iodide I 131 to allow sufficient time for involution to occur and to avoid excess concentration of sodium iodide I 131 in breast tissue. Consider administration of drugs to suppress lactation. Consider diagnostic scintigraphy before administration of sodium iodide I 131 to assess the persistence of uptake by breast tissue. If sodium iodide I 131 is administered in the postpartum period, the lactating mother should not breastfeed the infant [see Use in Specific Populations (8.2)].
(Newly added subsection)
Transient dose-related impairment of testicular function in men and transient ovarian insufficiency in women has been reported after sodium iodide I 131 therapy. Sperm banking for men may be considered prior to administration of HICON for thyroid carcinoma [see Use in Specific Populations (8.3)].
(Newly added subsection)
Household Contacts
Instruct patients to follow radiation safety precautions after receiving HICON to minimize the radiation contamination of other persons or the environment. Patients should avoid close contact with others, especially pregnant women and children, and take care to avoid contamination of other persons or the environment with body fluids.
Patients and Healthcare Providers
HICON contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Follow safe handling and administration to minimize radiation exposure to the patient and healthcare providers.
(Newly added subsection)
Certain food or drugs may alter the thyroid uptake of sodium iodide I 131 and diminish its effectiveness. Recent intake of stable iodide in any form, or the use of thyroid or anti-thyroid drugs may diminish thyroid uptake of sodium iodide I 131 [see Drug Interactions (7)].
6 Adverse Reactions
(Additions and/or revisions underlined)
The following clinically significant adverse reactions are described below and elsewhere in labeling:
Radiation-induced Thyroiditis [see Warnings and Precautions (5.1)].
Radiation-induced Toxicities [see Warnings and Precautions (5.2)].
Hypersensitivity Reactions [see Warnings and Precautions (5.3)].
Embryo-Fetal Toxicity [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)].
Increased Radiation Exposure to Breast Tissue with Lactation [see Warnings and Precautions (5.5), Use in Specific Populations (8.2)].
Transient Infertility [see Warnings and Precautions (5.6), Use in Specific Populations (8.3)].
Radiation Exposure to Other Individuals [see Warnings and Precautions (5.7)].
Risk of Decreased Effectiveness of Therapy [see Warnings and Precautions (5.8)].
(Newly added subsection; please refer to label)
7 Drug Interactions
(Additions and/or revisions underlined)
Concomitant use of bone marrow depressants may enhance the depression of the hematopoietic system caused by the use of large doses of sodium iodide I 131 [see Warnings and Precautions (5.2)].
Many drugs and iodide-containing foods interfere with the accumulation of radioiodide by the thyroid. Review the patient’s history, current medications, and recent diagnostic tests prior to the administration of sodium iodide I 131 [see Warnings and Precautions (5.8)].
- Advise patients to maintain a low-iodide diet two weeks prior to radioiodide administration and continue for several days during the uptake or imaging process and to discontinue taking the following products before they undergo the procedure as shown in Table 4.
Table 4 Pharmaceuticals / OTCs / Agents Blocking Radioiodine Uptake
…
8 Use in Specific Populations
8.1 Pregnancy(Additions and/or revisions underlined)
Risk Summary
HICON is contraindicated in pregnancy because fetal exposure can lead to neonatal hypothyroidism, which in some cases is severe and irreversible [See Warnings and Precautions (5.4)]. Data from the published literature describe reports of neonatal thyroid abnormalities after fetal exposure; including agenesis of the thyroid and hypothyroidism (see Clinical Considerations, Data). No animal reproductive studies have been conducted.
Clinical Considerations
Fetal/ Neonatal Adverse Reactions
A fetus exposed to sodium iodide I 131 can develop neonatal hypothyroidism. Delay in diagnosis of neonatal hypothyroidism after exposure to sodium iodide I 131 in utero can result in severe sequelae such as cognitive impairment and delayed bone age. Monitor thyroid function in any infant born after in utero exposure to sodium iodide I 131.
Data
Human Data
Sodium iodide I 131 crosses the placenta and the fetal thyroid begins to concentrate iodide during the 10th to 12th week of gestation. In literature reports of maternal exposures to sodium iodide I 131 at doses of 333 MBq to 8,325 MBq (9 mCi to 225 mCi) during 4 to 26 weeks gestational age, the most common adverse outcomes were hypothyroid infants and children.
(Additions and/or revisions underlined)
Risk Summary
HICON is contraindicated during lactation because I 131 concentrates in the breast during lactation via the increased expression of the sodium iodide symporter in breast tissue and can lead to hypothyroidism in the infant through breastfeeding. If sodium iodide I 131 is administered postpartum, breastfeeding should not be restarted for the remainder of the postpartum period. In addition, to minimize the absorbed radiation dose to the breast tissue, breastfeeding and breast-pumping should be discontinued for at least 6 weeks before administration of sodium iodide I 131 [see Data and Warnings and Precautions (5.5)].
Infants exposed to sodium iodide I 131 through breast milk are at risk for development of hypothyroidism because sodium iodide I 131 is distributed into breast milk and may reach concentrations equal to or greater than concentrations in maternal plasma (see Data).
Data
Published literature describes sodium iodide I 131 transfer into breast milk and uptake by the thyroid of the breastfed infant. The amount of sodium Iodide I 131 detected in the breast milk at 36 to 48 hours after administration is 1% to 27% of the injected dose (with injected doses between 1.1 MBq to 5,143 MBq).
(Additions and/or revisions underlined)
HICON is contraindicated in pregnancy because of the risk of fetal hypothyroidism [see Warnings and Precautions (5.4) and Use in Specific Populations (8.1)].
Pregnancy Testing
Obtain a pregnancy test in females of reproductive potential and verify the absence of pregnancy within 24 hours prior to administration of treatment [see Dosage and Administration (2.2)].
Contraception
Advise females and males of reproductive potential to use effective contraception during treatment with HICON and for at least six months after the last dose of HICON.
Infertility
Females
Fertility may be impaired with HICON treatment. Transient amenorrhea and ovarian insufficiency have been observed after sodium iodide I 131 therapy in females. The literature describes reports of transient menstrual cycle irregularities, including amenorrhea, and ovarian failure in females treated with cumulative doses of 1,000 MBq to 59,000 MBq (27 mCi to 1,595 mCi) sodium iodide I 131. In a published literature analysis, the effects on fertility occurred in up to 30% of women treated with sodium iodide I 131, and may resolve 12 months after treatment.
Males
Fertility may be impaired with HICON treatment. Discuss sperm banking for males who are expected to receive a high cumulative dose of sodium iodide I 131. Transient dose-related impairment of testicular function after sodium iodide I 131 therapy has been reported in the published literature. The literature describes reports of males treated with sodium iodide I 131 at doses of 370 MBq to 22,000 MBq (10 mCi to 595 mCi) resulting in transiently impaired testicular function (including spermatogenesis). The risk of persistent testicular dysfunction increases after administration of repeated or high cumulative radioiodide exposure.
(Additions and/or revisions underlined)
The safety and effectiveness of HICON have not been established in pediatric patients. Pediatric patients are at an increased lifetime risk for malignancy from radiation exposure.
(Additions and/or revisions underlined)
HICON is primarily excreted by the kidneys. Renal function impairment decreases excretion of sodium iodide I 131 and increases the radiation exposure and risk of radiation toxicity. For patients with a history of renal impairment, evaluate renal function for therapeutic planning and consider dosimetry. Sodium Iodide I 131 is dialyzable. Hemodialysis can be used to reduce total body radiation exposure [see Clinical Pharmacology (12.3)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION(Additions and/or revisions underlined)
Radiation Safety Precautions
Advise patients treated for hyperthyroidism to monitor for and seek medical care for signs and symptoms of thyrotoxicosis and thyroid storm arising during the post-treatment period. For mild radiation-induced thyroiditis, patients may be advised to consider symptomatic management with pain-relievers or anti-inflammatory medications [see Warnings and Precautions (5.1)].
Advise patients to hydrate and void frequently and to use a sialagogue after administration of radioiodide to minimize radiation dose [see Warnings and Precautions (5.2)].
- Advise patients to avoid close contact with others, especially pregnant women and children, and to take care to avoid contamination of other persons or the environment with body fluids [see Warnings and Precautions (5.7)].
Embryo-Fetal Toxicity
Advise female patients of the risk to a fetus [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)].
Advise females and males of reproductive potential to use effective contraception during treatment with HICON and for at least 6 months after the last dose [see Warnings and Precautions (5.4), Use in Specific Populations (8.3)].
- Advise female patients to contact their healthcare provider with a known or suspected pregnancy.
Lactation
- Instruct women to stop breastfeeding and breast-pumping for the remainder of the postpartum period after and for at least 6 weeks prior to HICON administration [see Contraindications (4), Warnings and Precautions (5.5), Use in Specific Populations (8.2)].
Effects on Fertility
Advise females and males of reproductive potential of the potential for impaired fertility with HICON treatment and possible use of sperm banking for males of reproductive potential [see Warnings and Precautions (5.6), Use in Specific Populations (8.3)].
07/08/2016 (SUPPL-42)
4 Contraindications
HICON is contraindicated in:
- Patients with vomiting and diarrhea
- Pregnancy
- Lactation
- Patients receiving concurrent anti-thyroid therapy
5 Warnings and Precautions
Fetal Toxicity- HICON® is contraindicated in pregnancy because sodium iodide I 131 crosses the placenta and fetal exposure can lead to neonatal hypothyroidism. Multiple reports in the published literature describe hypothyroidism in the neonates following in utero exposure to sodium iodide I 131. Some cases of neonatal hypothyroidism were severe and irreversible. Verify pregnancy status of females of reproductive potential prior to initiating HICON® treatment. Advise females and males of reproductive potential to use effective contraception during treatment with HICON® and for at least six months after the last dose.
- Hypersensitivity reactions including anaphylaxis may occur in patients who receive sodium iodide I 131. Although iodide is not considered an allergen, hypersensitivity reactions may occur in relation with excipients or chemical component of the capsule, such as sodium thiosulfate. Obtain and document an allergy history, particularly a sulfite allergy. Emergency resuscitation equipment and personnel should be immediately available.
- HICON® is contraindicated in lactating women because sodium iodide I 131 concentrates in the breast via the increased expression of the sodium iodide symporter in breast tissue with lactation. The literature describes moderate to marked radioiodine uptake in the breast tissue for 5-32 weeks post cessation of breast feeding. Advise lactating women to discontinue breast feeding at least 6 weeks prior to administration of sodium iodide I 131 to allow sufficient time for involution to occur and to avoid excess concentration of sodium iodide I 131 in breast tissue. Consider administration of drugs to suppress lactation. Consider diagnostic scintigraphy before administration of sodium iodide I 131 to assess the persistence of uptake by breast tissue. If sodium iodide I 131 is administered in the postpartum period, the lactating mother should not breastfeed the infant.
- Sodium iodide I 131 may cause thyroiditis with release of thyroid hormone, which may aggravate hyperthyroidism and thyrotoxic cardiac disease. When treating hyperthyroidism, consider pre-treatment anti-thyroid medication to help deplete the thyroid hormone. Discontinue the anti-thyroid therapy three days before administration of sodium iodide I 131. Consider a beta-blocker pre or post-treatment to minimize the risk of hyperthyroidism and thyroid storm.
- The thyroiditis may cause gland enlargement resulting in tenderness and swelling of the neck, pain on swallowing, sore throat, and cough; which may occur approximately the third day after sodium iodide I 131 administration. Consider management with pain-reliever or anti-inflammatory medications.
- Sodium Iodide I 131 may cause radiation induced toxicities:
- Dose-dependent fatalities (bone marrow suppression, malignancy).
- Dose-dependent hematopoietic suppression which manifests as a transient thrombocytopenia or neutropenia 3-5 weeks following sodium iodide I 131 administrations, may lead to increased susceptibility to infections or bleeding.
- Salivary gland toxicity: sialadenitis, xerostomia.
- Lacrimal gland toxicity: conjunctivitis, xerophthalmia, and epiphora.
- Obtain a complete blood count within one month of therapy. If patients show leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity, while delivering less than 2 Gy to the bone marrow.
- Advise good hydration for one week following sodium iodide I 131 administration and stimulate salivary flow via a sialagogue (e.g. sugar-free candy or gum, pilocarpine, and ascorbic acid) to reduce radiation exposure to the salivary glands.
- Advise patients to void frequently after administration of radioiodide to enhance excretion.
- Certain food or drugs may alter the thyroid uptake of sodium iodide I 131 and diminish its effectiveness. Recent intake of stable iodide in any form, or the use of thyroid or anti-thyroid drugs may diminish thyroid uptake of sodium iodide I 131.
Household Contacts
- Instruct patients to follow radiation safety precautions after receiving HICON® to minimize the radiation contamination of other persons or the environment. Patients should avoid close contact with others, especially pregnant women and children, and take care to avoid contamination of other persons or the environment with body fluids.
Patients and Healthcare Providers
- HICON® contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Follow safe handling and administration to minimize radiation exposure to the patient and healthcare providers.
- Transient dose-related impairment of testicular function in men and transient ovarian insufficiency in women has been reported after sodium iodide I 131 therapy. Consider sperm banking for men who are anticipated to receive cumulative sodium iodide I 131 doses greater than 19,000 MBq (520 mCi).
6 Adverse Reactions
- Gastrointestinal disorders: sialadenitis, salivary gland dysfunction, nausea, vomiting, gastritis.
- Cardiac disorders: chest pain, tachycardia.
- Skin and subcutaneous tissue disorders: itching, rash, hives.
- Endocrine disorders: hypothyroidism, hyperthyroidism, thyrotoxic crisis, hypoparathyroidism
- General disorders and administration site conditions: local swelling of thyroid or sites of iodide avid tumor.
- Hematologic and lymphatic disorders including fatalities: bone marrow depression, anemia, leukopenia, thrombocytopenia, and blood dyscrasia.
- Neoplasms benign, malignant and unspecified (including cysts and polyps): acute leukemia, solid cancer.
- Eye disorders: lacrimal gland dysfunction.
- Congenital, familial and genetic disorders: congenital hypothyroidism, chromosomal abnormalities.
- Immune system disorders: bronchospasm.
- Nervous system disorders: headache, *cerebral edema.
- Respiratory, thoracic and mediastinal disorders: **radiation pneumonitis, **pulmonary fibrosis.
* In patients with iodide-avid brain metastases
** In patients with iodide-avid lung metastases
- Radiation-induced Thyroiditis
- Radiation-induced Toxicities
- Hypersensitivity Reactions
- Fetal Toxicity
- Increased Radiation Exposure to Breast Tissue with Lactation
- Transient Infertility
- Radiation Exposure
7 Drug Interactions
- Concomitant use of bone marrow depressants may enhance the depression of the hematopoietic system caused by the use of large doses of sodium iodide I 131.
- Many drugs and iodide-containing foods interfere with the accumulation of radioiodide by the thyroid. Review the patient’s history, current medications, and recent diagnostic tests prior to the administration of sodium iodide I 131.
- Advise patients to maintain a low-iodide diet two weeks prior to radioiodide administration and continue for several days during the uptake or imaging process and to discontinue taking the following products before they undergo the procedure as shown in Table 3
8 Use in Specific Populations
Females and Males of Reproductive PotentialContraception
- Advise females and males of reproductive potential to use effective contraception during treatment with HICON® and for at least six months after the last dose of HICON.
Infertility
Females
- Fertility may be impaired with HICON® treatment. Transient amenorrhea and ovarian insufficiency have been observed after sodium iodide I 131 therapy in females. The literature describes reports of transient menstrual cycle irregularities, including amenorrhea, and ovarian failure in females treated with cumulative doses of 1000 – 59,000 MBq (27 – 1594 mCi) sodium iodide I 131.
Males
- Fertility may be impaired with HICON® treatment. Discuss sperm banking for males who are expected to receive a high cumulative dose of sodium iodide I 131. Transient dose-related impairment of testicular function after sodium iodide I 131 therapy has been reported in the published literature. The literature describes reports of males treated with sodium iodide I 131 at doses of 370 MBq – 22,000 MBq (10 – 595 mCi) resulting in transiently impaired testicular function (including spermatogenesis). Permanent impairment is described with high cumulative doses ranging from 19,000 – 29,000 MBq (520 – 800 mCi).
Risk Summary
- HICON® is contraindicated during lactation because I 131 concentrates in the breast during lactation via the increased expression of the sodium iodide symporter in breast tissue. If sodium iodide I 131 is administered in the postpartum period, the lactating mother should not breastfeed. In addition, to minimize the absorbed radiation dose to the breast tissue, breastfeeding and breast-pumping should be discontinued for at least 6 weeks before administration of sodium iodide I 131. Women may breast feed with the birth of another child. Infants exposed to sodium iodide I 131 through breast milk are at risk for development of hypothyroidism because sodium iodide I 131 is distributed into breast milk and may reach concentrations equal to or greater than concentrations in maternal plasma.
Data
Human Data
- Limited published literature describes sodium iodide I 131 transfer into breast milk and thyroidal uptake by the breastfed infant. The amount of sodium Iodide I 131 detected in the breast milk at 36-48 hours after administration is 1-27% of the injected dose (with injected doses between 1.1 – 5143 MBq).
- Addition of Pediatric patients are at an increased lifetime risk for malignancy from radiation exposure
Clinical Considerations
Fetal/ Neonatal Adverse Reactions
- Delay in diagnosis of neonatal hypothyroidism after exposure to sodium iodide I 131 in utero can result in severe sequelae such as decreased mental capacity and delayed bone age.
Data (updated)
Human Data
- Sodium iodide I 131 crosses the placenta and the fetal thyroid begins to concentrate iodide during the 10-12th week of gestation. In literature reports of maternal exposures to sodium iodide I 131 at doses of 333 – 8325 MBq (9 – 225 mCi) during 4-26 weeks gestational age, the most common adverse outcomes were hypothyroid infants and children.
- HICON® is primarily excreted by the kidneys. Renal function impairment decreases excretion of sodium iodide I 131 and increases the radiation exposure and risk of radiation toxicity. For patients with a history of renal impairment, evaluate renal function for therapeutic planning and consider dosimetry. Sodium Iodide I 131 is dialyzable. Hemodialysis can be used to reduce total body radiation exposure.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Lactation- Instruct women to stop breastfeeding and breast-pumping at least 6 weeks prior to HICON® administration Effects on Fertility
- Advise females and males of reproductive potential of the potential for impaired fertility with HICON® treatment.
- Advise female patients of the risk to a fetus.
- Advise females and males of reproductive potential to use effective contraception during treatment with HICON® and for at least 6 months after the last dose.
- Advise female patients to contact their healthcare provider with a known or suspected pregnancy.
- Review the most recent professional society guidelines and publications that describe important components of the patient counseling process and discuss measures to minimize inadvertent radiation exposure to the patient.