The following Structured Product Label (SPL) was submitted to the FDA by Nova Laboratories, Ltd. for the product Xromi (NDC 62484-0015). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding warning: myelosuppression and malignancies, 1 indications and usage, 2.1 recommended dosage, 2.2 administration instructions, 2.3 dosage modifications in renal impairment, 3 dosage forms and strengths, 4 contraindications, 5.1 myelosuppression, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
XROMI is indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age to less than 2 years, with sickle cell anemia with recurrent moderate to severe painful crises.
The recommended XROMI dosage in pediatric patients aged 6 months to less than 2 years is described in Table 1.
Dosing Regimen | Dose | Dose modification criteria | Monitoring parameters |
Initial Recommended dosing | 15 mg/kg/day (rounded to nearest 10 mg) orally as a single dose once daily based on the patient’s actual body weight. | Monitor the patient’s complete blood count (CBC) with differential and reticulocyte count every 2 weeks while adjusting dosage [see Warnings and Precautions (5.1)]. | |
Dosing Adjustment Based on Blood Counts in the acceptable range |
Increase dose 5 mg/kg/day every 8 to12 weeks. | Increase dose only if blood counts are in an acceptable range. | Target Blood Counts |
Dosing Adjustment Based on Blood Counts below acceptable range | Do not increase dose. | If blood counts are considered toxic, discontinue XROMI until hematologic recovery. | Blood Counts Toxic Range
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Dosing after Hematologic Recovery | If hematologic toxicity resolved within 1 week, restart at the same XROMI dose. | Once a stable dose is established, monitor CBC with differential and reticulocyte count every 4 weeks for 2 months and then as clinically indicated. |
Caregivers must be able to follow directions regarding drug administration and their monitoring and care.
If a dose of XROMI is missed at the scheduled time, the patient should take the missed dose as soon as possible once it is noticed, but only on the same day. If this is not possible, the patient should skip the dose and continue with the next dose as prescribed.
The patient should not take two doses to make up for a missed dose.
Fetal hemoglobin (HbF) levels may be used to evaluate the efficacy of XROMI in clinical use. Obtain HbF levels every three to four months. Monitor for an increase in HbF of at least two-fold over the baseline value.
XROMI causes macrocytosis, which may mask the incidental development of folic acid deficiency. Prophylactic administration of folic acid is recommended.
XROMI is for oral use. See Instructions for Use for details on preparation and administration of XROMI for oral solution.
Do not shake.
Two dosing oral syringes (a red oral dosing syringe graduated to 3 mL and a white oral dosing syringe graduated to 12 mL) are provided for accurate measurement of the prescribed dose of the oral solution. It is recommended that the healthcare professional advises the caregiver which oral dosing syringe to use to ensure that the correct volume is administered.
The smaller 3 mL oral dosing syringe (red), marked from 0.5 mL to 3 mL, is for measuring doses of less than or equal to 3 mL. This oral dosing syringe should be recommended for doses less than or equal to 3 mL (each graduation of 0.1 mL contains 10 mg of hydroxyurea).
The larger 12 mL oral dosing syringe (white), marked 1 mL to 12 mL, is for measuring doses of more than 3 mL. This oral dosing syringe should be recommended for doses greater than 3 mL (each graduation of 0.25 mL contains 25 mg of hydroxyurea).
XROMI may be taken with or after meals at any time of the day but caregivers should standardize the method of administration and time of day.
XROMI is a hazardous drug. Follow applicable special handling and disposal procedures
[see Reference (15)].
Reduce the dose of XROMI by 50% in patients with creatinine clearance of less than 60 mL/min or with end-stage renal disease (ESRD) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. Creatinine clearance were obtained using 24-hour urine collections.
| Creatinine Clearance (mL/min) | Recommended XROMI Initial Dose |
| Greater than or equal to 60 | 15 mg/kg once daily |
| Less than 60 or ESRD* | 7.5 mg/kg once daily |
| * On dialysis days, administer XROMI to patients with ESRD following hemodialysis |
Monitor the hematologic parameters closely in these patients.
Oral solution: 100 mg/mL clear colorless to pale yellow liquid in a multiple-dose amber bottle.
XROMI is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation. [see Adverse Reactions (6)].
Hydroxyurea causes severe myelosuppression. Do not initiate treatment with XROMI in patients if bone marrow function is markedly depressed. Bone marrow suppression may occur, and leukopenia is generally its first and most common manifestation. Thrombocytopenia and anemia occur less often and are seldom seen without a preceding leukopenia.
Some patients, treated at the recommended initial dose of 15 mg/kg/day, have experienced severe or life-threatening myelosuppression.
Evaluate hematologic status (CBC, reticulocyte count) prior to and every 2 weeks during dose-escalation period of XROMI treatment. Once a stable dose of XROMI is achieved, monitor every 4 weeks. Provide supportive care and modify dose or discontinue XROMI as needed. Recovery from myelosuppression is usually rapid when therapy is interrupted. [see Dosage and Administration (2.1)].
Cases of hemolytic anemia in patients treated with hydroxyurea for myeloproliferative diseases have been reported [see Adverse Reactions (6.1)]. Patients who develop acute jaundice or hematuria in the presence of persistent or worsening of anemia should have laboratory tests evaluated for hemolysis (e.g., measurement of serum lactate dehydrogenase, haptoglobin, reticulocyte, unconjugated bilirubin levels, urinalysis, and direct and indirect antiglobulin [Coombs] tests). In the setting of confirmed diagnosis of hemolytic anemia and in the absence of other causes, discontinue XROMI.
Hydroxyurea is a human carcinogen. In patients receiving long-term hydroxyurea for myeloproliferative disorders (a condition for which XROMI is not approved), secondary leukemia has been reported.
Secondary leukemia has also been reported in patients treated with long-term hydroxyurea for sickle cell anemia. Leukemia has also been reported in patients with sickle cell anemia and no prior history of treatment with hydroxyurea.
All patients using XROMI should be followed up on a long-term basis with regular blood counts to detect development of leukemia.
Skin cancer has also been reported in patients receiving long-term hydroxyurea. Advise protection from sun exposure and monitor for the development of secondary malignancies.
Based on the mechanism of action and findings in animals, XROMI can cause fetal harm when administered to a pregnant woman. Hydroxyurea was embryotoxic and teratogenic in rats and rabbits at doses 0.8 times and 0.3 times, respectively, the maximum recommended human daily dose on a mg/m2 basis.
Cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, have occurred in patients with myeloproliferative disorders during therapy with hydroxyurea. These vasculitic toxicities were reported most often in patients with a history of, or currently receiving, interferon therapy. If cutaneous vasculitic ulcers occur, institute treatment and discontinue XROMI.
Avoid use of live vaccines in patients taking XROMI. Concomitant use of XROMI with a live virus vaccine may potentiate the replication of the virus and/or may increase the adverse reaction of the vaccine because normal defense mechanisms may be suppressed by XROMI. Vaccination with live vaccines in a patient receiving XROMI may result in severe infection [see Drug Interactions (7.2)]. Patient’s antibody response to vaccines may be decreased. Consider consultation with a specialist.
Pancreatitis, hepatotoxicity, and peripheral neuropathy have occurred when hydroxyurea was administered concomitantly with antiretroviral drugs, including didanosine and stavudine [see Drug Interactions (7.1)].
XROMI may cause macrocytosis, which is self-limiting, and is often seen early in the course of treatment. The morphologic change resembles pernicious anemia, but is not related to vitamin B12 or folic acid deficiency. This may mask the diagnosis of pernicious anemia. Prophylactic administration of folic acid is recommended.
Interstitial lung disease including pulmonary fibrosis, lung infiltration, pneumonitis, and alveolitis/allergic alveolitis (including fatal cases) have been reported in patients treated for myeloproliferative neoplasm. Safety and effectiveness have not been established for the use of XROMI in the treatment of myeloproliferative neoplasms and the use is not approved by the FDA. Monitor patients developing pyrexia, cough, dyspnea, or other respiratory symptoms frequently, investigate and treat promptly. Discontinue XROMI and manage with corticosteroids [see Adverse Reactions (6.1)].
Interference with uric acid, Urea, or lactic acid assays is possible, rendering falsely elevated results of these in patients treated with hydroxyurea [see Drug Interactions (7.2)].
Hydroxyurea may falsely elevate sensor glucose results from certain continuous glucose monitoring (CGM) systems and may lead to hypoglycemia if sensor glucose results are relied upon to dose insulin.
If a patient using a CGM is to be prescribed hydroxyurea, consult with the CGM prescriber about alternative glucose monitoring methods [see Drug Interactions (7.2)].
The following clinically significant adverse reactions are described in detail in other labeling sections:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of XROMI was evaluated in 32 pediatric patients aged 10 months -16 years with sickle cell anemia in a single-arm, open-label, prospective, multi-center, pharmacokinetic, safety and efficacy study (HUPK study). Only adverse reactions associated with the use of XROMI in pediatric patients aged 10 months to less than 2 years are presented.
The most frequently reported adverse reactions in HUPK study (>33%) were neutropenia, and thrombocytopenia [see Table 3].
| 10 Months–<2 Years | |
| Body System Adverse Reactions | (n=6)% |
| Neutropenia | 50 |
| Thrombocytopenia | 33 |
| Diarrhea | 17 |
| Absolute Reticulocyte Count Decreased | 17 |
The following adverse reactions have been identified during post-approval use of hydroxyurea. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
Pancreatitis
In patients with HIV infection during therapy with hydroxyurea and didanosine, with or without stavudine, fatal and nonfatal cases of pancreatitis have occurred.
Hydroxyurea is not indicated for the treatment of HIV infection; however, if patients with HIV infection are treated with hydroxyurea, and in particular, in combination with didanosine and/or stavudine, close monitoring for signs and symptoms of pancreatitis is recommended. Permanently discontinue therapy with hydroxyurea in patients who develop signs and symptoms of pancreatitis.
Hepatotoxicity
Hepatotoxicity and hepatic failure resulting in death have been reported during postmarketing surveillance in patients with HIV infection treated with hydroxyurea and other antiretroviral drugs. Fatal hepatic events were reported most often in patients treated with the combination of hydroxyurea, didanosine, and stavudine. Avoid this combination.
Peripheral Neuropathy
Peripheral neuropathy, which was severe in some cases, has been reported in patients with HIV infection receiving hydroxyurea in combination with antiretroviral drugs, including didanosine, with or without stavudine.
XROMI is not approved in males or females of reproductive potential.
Infertility
Males
Based on findings in animals and humans, male fertility may be compromised by treatment with XROMI. Azoospermia or oligospermia, sometimes reversible, has been observed in men. [see Nonclinical Toxicology (13.1)].
Absorption
Following oral administration of XROMI, hydroxyurea reaches peak plasma concentrations in 0 to 2 hours. Mean peak plasma concentrations and AUCs increase more than proportionally with increase of dose.
Effect of Food
There are no data on the effect of food on the absorption of hydroxyurea.
Distribution
Hydroxyurea distributes throughout the body with a volume of distribution approximating total body water.
Hydroxyurea concentrates in leukocytes and erythrocytes.
Elimination
Metabolism
Up to 60% of an oral dose undergoes conversion through saturable hepatic metabolism and a minor pathway of degradation by urease found in intestinal bacteria.
Excretion
In patients with sickle cell anemia, the mean cumulative urinary recovery of hydroxyurea was about 40% of the administered dose.
Specific Populations
Renal Impairment
The effect of renal impairment on the pharmacokinetics of hydroxyurea was assessed in adult patients with sickle cell disease and renal impairment.
Patients with normal renal function (creatinine clearance [CrCl] >80 mL/min), mild (CrCl 50-80 mL/min), moderate (CrCl =30-<50 mL/min), or severe (<30 mL/min) renal impairment received a single oral dose of 15 mg/kg hydroxyurea.
Creatinine clearance values were obtained using 24-hour urine collections. Patients with ESRD received two doses of 15 mg/kg separated by 7 days; the first was given following a 4-hour hemodialysis session, the second prior to hemodialysis.
The exposure to hydroxyurea (mean AUC) in patients with CrCl <60 mL/min and those with ESRD was 64% higher than in patients with normal renal function (CrCl >60 mL/min).
[see Dosage and Administration (2.2) and Use in Specific Populations (8.6)].
Pediatric Patients
The model estimated steady state exposures (AUC) in pediatric patients receiving a daily dose of 15 mg/kg is lower in patients aged 6 months to <2 years by 40% compared to adults receiving the same dose (XROMI is not approved for use in adults).
Studies have shown that there is an analytical interference of hydroxyurea with the enzymes (urease, uricase, and lactate dehydrogenase) used in the determination of urea, uric acid, and lactic acid, rendering falsely elevated results of these in patients treated with hydroxyurea.
Interference with Continuous Glucose Monitoring Systems
Hydroxyurea may falsely elevate sensor glucose results from certain continuous glucose monitoring (CGM) systems and may lead to hypoglycemia if sensor glucose results are relied upon to dose insulin.
If a patient using a CGM is to be prescribed hydroxyurea, consult with the CGM prescriber about alternative glucose monitoring methods.
The safety and effectiveness of XROMI have been established in pediatric patients aged 6 months to less than 2 years with sickle cell anemia with recurrent moderate to severe painful crises. Use of XROMI in these age groups is supported by evidence from a pharmacokinetic, efficacy and safety study, in which 32 pediatric patients ages 6 months to <18 years were enrolled. Among the 32 pediatric patients treated with XROMI, 6 were infants (6 months – 2years). The safety and effectiveness of XROMI have not been established in pediatric patients less than 6 months of age. Continuous follow-up of the growth of treated children is recommended.
The exposure to XROMI is higher in patients with creatinine clearance of less than 60 mL/min. Reduce dosage and closely monitor the hematologic parameters when XROMI is to be administered to these patients [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)].
There are no data that support specific guidance for dosage adjustment in patients with hepatic impairment. Close monitoring of hematologic parameters is advised in these patients.
Acute mucocutaneous toxicity and neutropenia has been reported in patients receiving hydroxyurea at doses several times above the therapeutic dose. Soreness, violet erythema, oedema on palms and soles followed by scaling of hand and feet, severe generalized hyperpigmentation of the skin and stomatitis have been observed.
XROMI (hydroxyurea) is an antimetabolite available for oral use as oral solution containing 100 mg/mL hydroxyurea. Inactive ingredients include methyl parahydroxybenzoate, purified water, sodium hydroxide, strawberry flavor, sucralose and xanthan gum.
Hydroxyurea is a white to off-white crystalline powder. It is hygroscopic and freely soluble in water, but practically insoluble in alcohol. The empirical formula is CH4N2O2 and it has a molecular weight of 76.05. Its structural formula is:
Chemical Structure (Xromi 01)
The precise mechanism by which hydroxyurea produces its cytotoxic and cytoreductive effects is not known. However, various studies support the hypothesis that hydroxyurea causes an immediate inhibition of DNA synthesis by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of ribonucleic acid or of protein.
The mechanisms by which XROMI produces its beneficial effects in patients with sickle cell anemia are uncertain. Known pharmacologic effects of XROMI that may contribute to its beneficial effects include increasing HbF levels in red blood cells (RBCs), decreasing neutrophils, increasing the water content of RBCs, increasing deformability of sickled cells, and altering the adhesion of RBCs to endothelium.
In pediatric patients treated with hydroxyurea for up to 15 months, the ratio of fetal hemoglobin to total hemoglobin was 25%, at the end of the study, representing a change from baseline increase of 9% in patients aged 6 months to <2 years.
Conventional long-term studies to evaluate the carcinogenic potential of hydroxyurea have not been performed. However,
intraperitoneal administration of 125 to 250 mg/kg hydroxyurea (about 0.6-1.2 times the maximum recommended human oral daily dose on a mg/m2 basis) thrice weekly for 6 months to female rats increased the incidence of mammary tumors in rats surviving to 18 months compared to control.
Hydroxyurea is mutagenic in vitro to bacteria, fungi, protozoa, and mammalian cells. Hydroxyurea is clastogenic in vitro (hamster cells, human lymphoblasts) and in vivo (SCE assay in rodents, mouse micronucleus assay). Hydroxyurea causes the transformation of rodent embryo cells to a
tumorigenic phenotype [see Warnings and Precautions (5.3 , 5.4)].
Hydroxyurea administered to male rats at 60 mg/kg /day (about 0.3 times the maximum recommended human daily dose on a mg/m2 basis) produced testicular atrophy, decreased spermatogenesis and significantly reduced their ability to impregnate females [see Use in Specific Populations (8.3)].
The effectiveness of XROMI has been established for the indication, “to reduce the frequency of painful crises and to reduce the need for blood transfusions in pediatric patients aged 6 months to less than 2 years with sickle cell anemia with recurrent moderate to severe painful crises” based on an adequate and well-controlled study of hydroxyurea capsules in adult patients with sickle cell anemia with recurrent moderate to severe pain crises and additional pharmacokinetic data from a single-arm, open-label study of XROMI in pediatric patients aged 10 months to less than 2 years with sickle cell anemia, who were treatment naïve or had not received hydroxyurea in the 6 months prior to enrollment: HUPK study [see Adverse Reactions (6.1)].
OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
XROMI (hydroxyurea) 100 mg/mL is a colorless to pale yellow liquid supplied in an Amber type III glass bottle with tamper evident child-resistant closure (HDPE with expanded polyethylene liner) containing 150 mL of oral solution.
Each carton NDC 62484-0015-2 contains 1 bottle XROMI NDC 62484-0015-1, an LDPE bottle adaptor and 2 oral dosing syringes (a red oral dosing syringe graduated to 3 mL and a white oral dosing syringe graduated to 12 mL).
Store XROMI between 2°C to 8°C (35°F to 46°F) excursions permitted to 25°C (77°F) for up to 72 hours. Keep the bottle tightly closed to protect the integrity of the product and minimize the risk of accidental spillage. Do not freeze.
Use within 12 weeks after initially opening the bottle. Discard unused XROMI remaining after 12 weeks of first opening the bottle.
XROMI is a hazardous drug. Follow applicable special handling and disposal procedures [see References (15)].
Anyone handling XROMI should wash their hands before and after administering a dose. To decrease the risk of exposure, parents and caregivers should wear disposable gloves when handling XROMI. To minimize air bubbles, the bottle should not be shaken prior to dosing. XROMI contact with skin or mucous membrane must be avoided. If XROMI comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water. Spillages must be wiped immediately with a damp disposable towel and discarded in a closed container, such as a plastic bag.
The spill areas should be cleaned three times using a detergent solution followed by clean water. If contact with XROMI occurs in the eye(s), flush the eye(s) thoroughly with water or isotonic eyewash designated for that purpose for at least 15 minutes. Women who are pregnant, planning to be or breast-feeding should not handle XROMI. Parents / care givers should be advised to keep hydroxyurea out of the sight and reach of children. Accidental ingestion can be lethal for children.
Oral dosing syringes should be rinsed and washed with cold or warm water and dried completely before the next use. Store oral dosing syringes in a hygienic place with the medicine.
Advise the caregiver to read the FDA-approved patient labeling (Instructions for Use and Medication Guide).
Because XROMI package includes two oral dosing syringes, advise patients on which oral dosing syringe they should use.
Manufactured by:
Nova Laboratories Ltd.
Leicester
LE18 4YL
United Kingdom
Manufactured for:
Rare Disease Therapeutics, Inc.
2550 Meridian Blvd., Suite 150
Franklin, Tennessee 37067
www.raretx.com
Part Number: D001229/1
| This Medication Guide has been approved by the U.S. Food and Drug Administration. | Issued: APR/2024 | ||
| MEDICATION GUIDE XROMI® (ex-ro-mee) (hydroxyurea) oral solution | |||
What is the most important information I should know about XROMI? XROMI can cause serious side effects including:
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| What is XROMI? XROMI is a prescription medicine that is used to reduce the frequency of painful crises and reduce the need for blood transfusions in children aged 6 months to less than 2 years old, with sickle cell anemia with recurrent moderate to severe painful crises. XROMI is not for use in adults. It is not known if XROMI is safe and effective in children less than 6 months old. | |||
| Who should not take XROMI? Your child should not take XROMI if your child is allergic to hydroxyurea or any of the ingredients in XROMI. See the end of this Medication Guide for a list of the ingredients in XROMI. | |||
Before your child takes XROMI, tell your child's healthcare provider about all of their medical conditions, including if your child:
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Tell your healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. | |||
How should your child take XROMI? Read the Instructions for Use that comes with XROMI for information about the right way to measure and give a dose of XROMI. If you have any questions, talk to your child's healthcare provider or pharmacist.
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What are the possible side effects of XROMI?
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The most common side effects of XROMI include:
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| These are not all the possible side effects of XROMI. Call your child's doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |||
How should I store XROMI?
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| Keep XROMI and all medicines out of the reach of children. | |||
| General information about the safe and effective use of XROMI Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use XROMI for a condition for which it was not prescribed. Do not give XROMI to other people, even if they have the same symptoms your child has. It may harm them. You can ask your child's healthcare provider or pharmacist for information about XROMI that is written for health professionals. | |||
| What are the ingredients of XROMI? Active ingredient: hydroxyurea Inactive ingredients: methyl parahydroxybenzoate, purified water, sodium hydroxide, strawberry flavor, sucralose and xanthan gum. Manufactured by: Nova Laboratories Ltd., Leicester, LE18 4YL, United Kingdom | |||
| INSTRUCTIONS FOR USE XROMI®(ex-ro-mee) hydroxyurea) oral solution |
Read these Instructions for Use before your child starts taking XROMI, and each time you get a refill. There may be new information. This Instructions for Use does not take the place of talking to your child's healthcare provider about your child's medical condition or treatment.
Important information:
Picture Of Bottle And Oral Dispensing Syringes (Xromi 02)
If your carton does not contain 2 oral dosing syringes, contact your pharmacist.
You will also need disposable gloves.
| Before giving XROMI: | |
| Step 1. Wash your hands well with soap and water. | |
| Step 2. Put on disposable gloves. | |
| Step 3. Place the items from the carton on a clean flat surface. | |
| Step 4. Open the bottle by pushing down firmly on the child-resistant cap and turning it counter-clockwise (See Figure A). Do not throw away the child-resistant cap. |  Figure A (Xromi 03) |
| Step 5. First time use only: Insert the bottle adapter. Push the ribbed end of the bottle adapter into the neck of the bottle until it is firmly in place. The bottom edge of the adapter should fully contact the top rim of the bottle (See Figure B). Do not remove the adapter from the bottle after it is inserted. |  Figure B (Xromi 04) |
| Measuring your child's prescribed dose of XROMI: | |
| Step 6. Choose the oral dosing syringe you need to measure your child's prescribed dose. (See Figure C). Check the dose in mL as prescribed by your child’s healthcare provider. Choose the right oral dosing syringe for your child’s dose.
Find the marking for your child’s prescribed dose on the right oral dosing syringe. |  Figure C (Xromi 05) |
| Step 7. Push the plunger of the oral dosing syringe all the way down to remove any air in the oral dosing syringe (See Figure D). |  Figure D (Xromi 06) |
| Step 8. Hold the bottle upright. Insert the tip of the oral dosing syringe into the opening of the bottle adapter until it is firmly in place (See Figure E). |  Figure E (Xromi 07) |
| Step 9. Turn the bottle upside down with the oral dosing syringe in place. Pull back slowly on the plunger of the oral dosing syringe until the top of the plunger is even with the mL mark on the oral dosing syringe that corresponds to your child’s prescribed dose. See Figure F for an example of a dose of 6 mL. Your dose may be different than the example shown. |  Figure F (Xromi 08) |
| Step 10. Leave the oral dosing syringe in the bottle adapter and turn the bottle upright. Place the bottle onto a flat surface. Hold the oral dosing syringe by the barrel and carefully remove it from the adapter. Do not hold the oral dosing syringe by the plunger (See Figure G). |  Figure G (Xromi 09) |
| Step 11. Hold the oral dosing syringe with the oral dosing syringe tip pointing up. Check that the correct dose was drawn up into the oral dosing syringe (See Figure H). If there are large air bubbles in the oral dosing syringe (See Figure I) or if you have drawn up the wrong dose, re-insert the oral dosing syringe tip firmly into the bottle adapter while the bottle is in an upright position. Fully push in the plunger so the oral solution flows back into the bottle. Repeat Steps 8 and 9. |  Figure H (Xromi 10)  Figure I (Xromi 11) |
| Giving the prescribed dose of XROMI: | |
| Step 12. Place the tip of the oral dosing syringe in your child’s mouth and place the tip against the inside of your child’s cheek. Gently push the plunger all the way down to give all the medicine in the oral dosing syringe and then remove the oral dosing syringe from your child’s mouth (See Figure J). Make sure the child has time to swallow the medicine. If your child’s prescribed dose is more than 12 mL, you will need to divide the dose. Follow the instructions given to you by your healthcare provider or pharmacist about how to divide the dose and repeat Steps 6 through 12. |  Figure J (Xromi 12) |
| Step 13. Have your child drink some water to make sure no medicine is left in your child’s mouth. | |
| Step 14. Close the bottle tightly by turning the child-resistant cap clockwise, leaving the bottle adapter in place. | |
| Step 15. Wash your hands well with soap and water. Wash the oral dosing syringe with cold or warm soapy water and rinse well. Hold the oral dosing syringe under water and move the plunger up and down several times to make sure the inside of the oral dosing syringe is clean. Let the oral dosing syringe dry completely before you use it again. Do not throw away the oral dosing syringe after use. |
Storing XROMI
Manufactured by: Nova Laboratories Ltd., Leicester, LE18 4YL, United Kingdom
Manufactured for: Rare Disease Therapeutics, Inc., 2550 Meridian Blvd., Suite 150, Franklin, TN 37067
Part Number: D001231/1
This “Instructions for Use” has been approved by the U.S. Food and Drug Administration Revised: APR 2024
* Please review the disclaimer below.
