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Kapvay

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Kapvay

Side Effects
Interactions

SIDE EFFECTS

Clinical Trial Experience

Two KAPVAY ADHD clinical studies evaluated 256 patients who received active therapy, in one of the two placebo-controlled studies (Studies 1 and 2) with primary efficacy end-points at 5-weeks.

Study 1: Fixed-dose KAPVAY Monotherapy

Study 1 was a multi-center, randomized, double-blind, placebo-controlled study with primary efficacy endpoint at 5 weeks, of two fixed doses (0.2 mg/day or 0.4 mg/day) of KAPVAY in children and adolescents (6 to 17 years of age) who met DSM-IV criteria for ADHD hyperactive or combined inattentive/hyperactive subtypes.

Commonly observed adverse reactions (incidence of ≥ 2% in either active treatment group and greater than the rate on placebo) during the treatment period are listed in Table 2.

Table 2 : Common Adverse Reactions in the Fixed-Dose Monotherapy Trial- Treatment period (Study 1)

Preferred Term Percentage of Patients Reporting Event
KAPVAY 0.4 mg/day
N=78
KAPVAY 0.2 mg/day
N=76
Placebo
(N=76)
Somnolence* 31% 38% 5%
Headache 19% 29% 18%
Upper Abdominal Pain 13% 20% 17%
Fatigue† 13% 16% 1%
Upper Respiratory Tract Infection 6% 11% 4%
Irritability 6% 9% 3%
Throat Pain 6% 8% 3%
Nausea 8% 5% 4%
Nightmare 9% 3% 0
Dizziness 3% 7% 5%
Insomnia 6% 4% 1%
Emotional Disorder 5% 4% 1%
Constipation 6% 1% 0
Dry Mouth 5% 0 1%
Nasal Congestion 5% 3% 1%
Body Temperature Increased 1% 5% 3%
Gastrointestinal Viral 0% 7% 4%
Diarrhea 1% 4% 3%
Ear Pain 0 5% 1%
Nasopharyngitis 3% 3% 1%
Abnormal Sleep-Related Event 1% 3% 0
Aggression 1% 3% 1%
Asthma 1% 3% 1%
Bradycardia 4% 0 0
Enuresis 4% 0 0
Influenza like Illness 3% 1% 1%
Tearfulness 3% 1% 0
Thirst 3% 1% 0
Tremor 3% 1% 0
Epistaxis 0 3% 0
Lower Respiratory Tract Infection 0 3% 1%
Pollakiuria 0 3% 0
Sleep Terror 0 3% 0
* Somnolence includes the terms “somnolence” and “sedation”.
†Fatigue includes the terms “fatigue” and “lethargy”.

Commonly observed adverse reactions (incidence of ≥ 2% in either active treatment group and greater than the rate on placebo) during the taper period are listed in Table 3.

Table 3 : Common Adverse Reactions in the Fixed-Dose Monotherapy Trial- Taper period* (Study 1)

Preferred Term Percentage of Patients Reporting Event
KAPVAY 0.4 mg/day
N=78
KAPVAY 0.2 mg/day
N=76
Placebo
(N=76)
Abdominal Pain Upper 6% 0 3%
Headache 2% 5% 3%
Gastrointestinal Viral 5% 0 0
Somnolence 3% 2% 0
Heart Rate Increased 3% 0 0
Otitis Media Acute 0 3% 0
*Taper Period: 0.2 mg dose, week 8; 0.4 mg dose, weeks 6-8; Placebo dose, weeks 6-8

Study 2: Flexible-dose KAPVAY as Adjunctive Therapy to Psychostimulants

Study 2 was a multi-center, randomized, double-blind, placebo-controlled study, with primary efficacy endpoint at 5 weeks, of a flexible dose of KAPVAY as adjunctive therapy to a psychostimulant in children and adolescents (6 to 17 years) who met DSM-IV criteria for ADHD hyperactive or combined inattentive/hyperactive subtypes. KAPVAY was initiated at 0.1 mg/day and titrated up to 0.4 mg/day over a 3-week period. Most KAPVAY treated patients (75.5%) were escalated to the maximum dose of 0.4 mg/day.

Commonly observed adverse reactions (incidence of ≥ 2% in the treatment group and greater than the rate on placebo) during the treatment period are listed in Table 4.

Table 4 : Common Adverse Reactions in the Flexible-Dose Adjunctive to Stimulant Therapy Trial- Treatment Period (Study 2)

Preferred Term Percentage of Patients Reporting Event
KAPVAY+STM
(N=102)
PBO+STM
(N=96)
Somnolence* 19% 8%
Fatigue† 16% 4%
Abdominal Pain Upper 12% 7%
Nasal Congestion 6% 5%
Throat Pain 6% 3%
Decreased Appetite 5% 4%
Body Temperature Increased 4% 2%
Dizziness 4% 2%
Insomnia 4% 2%
Epistaxis 3% 0
Rhinorrhea 3% 0
Abdominal Pain 2% 1%
Anxiety 2% 0
Pain in Extremity 2% 0
* Somnolence includes the terms: “somnolence” and “sedation”.
†Fatigue includes the terms “fatigue” and “lethargy”.

Commonly observed adverse reactions (incidence of ≥ 2% in the treatment group and greater than the rate on placebo) during the taper period are listed in Table 5.

Table 5 : Common Adverse Reactions in the Flexible-Dose Adjunctive to Stimulant Therapy Trial- Taper Period* (Study 2)

Preferred Term Percentage of Patients Reporting Event
KAPVAY+STM
(N=102)
PBO+STM
(N=96)
Nasal Congestion 4% 2%
Headache 3% 1%
Irritability 3% 2%
Throat Pain 3% 1%
Gastroenteritis Viral 2% 0
Rash 2% 0
*Taper Period: weeks 6-8

Most common adverse reactions, defined as events that were reported in at least 5% of drug-treated patients and at least twice the rate as in placebo patients, during the treatment period were somnolence, fatigue, upper respiratory tract infection, irritability, throat pain, insomnia, nightmares, emotional disorder, constipation, nasal congestion, increased body temperature, dry mouth, and ear pain. The most common adverse reactions that were reported during the taper phase were upper abdominal pain and gastrointestinal virus.

Adverse Reactions Leading to Discontinuation

Thirteen percent (13%) of patients receiving KAPVAY discontinued from the pediatric monotherapy study due to adverse events, compared to 1% in the placebo group. The most common adverse reactions leading to discontinuation of KAPVAY monotherapy treated patients were from somnolence/sedation (5%) and fatigue (4%). Less common adverse reactions leading to discontinuation (occurring in approximately 1% of patients) included: formication, vomiting, prolonged QT, increased heart rate, and rash. In the pediatric adjunctive treatment to stimulants study, one patient discontinued from KAPVAY + stimulant group because of bradyphrenia.

Effects on Laboratory Tests, Vital Signs, and Electrocardiograms

KAPVAY treatment was not associated with any clinically important effects on any laboratory parameters in either of the placebo-controlled studies.

Mean decreases in blood pressure and heart rate were seen [see WARNINGS AND PRECAUTIONS].

There were no changes on ECGs to suggest a drug-related effect.

Postmarketing Experience

Hallucinations and atrioventricular (AV) block have been identified during post approval use of Kapvay. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Read the Kapvay (clonidine hydrochloride extended-release tablets) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No drug interaction studies have been conducted with KAPVAY in children. The following have been reported with other oral immediate release formulations of clonidine.

Interactions with CNS-depressant Drugs

Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs.

Interactions with Tricyclic Antidepressants

If a patient is receiving clonidine hydrochloride and also taking tricyclic antidepressants the hypotensive effects of clonidine may be reduced.

Interactions with Drugs Known to Affect Sinus Node Function or AV Nodal Conduction

Due to a potential for additive effects such as bradycardia and AV block, caution is warranted in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction (e.g., digitalis, calcium channel blockers and beta-blockers).

Use with other products containing clonidine

Do not use KAPVAY concomitantly with other products containing clonidine (e.g. Catapres®).

Antihypertensive Drugs

Use caution when KAPVAY is administered concomitantly with antihypertensive drugs, due to the potential for additive pharmacodynamic effects (e.g., hypotension, syncope) [see WARNINGS AND PRECAUTIONS].

Drug Abuse And Dependence

Controlled Substance

KAPVAY is not a controlled substance and has no known potential for abuse or dependence.

Last reviewed on RxList: 2/22/2013
This monograph has been modified to include the generic and brand name in many instances.

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