MSD IMPLANON, Справочное руководство

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applicator seal
obturator support
obturator
applicator
location of IMPLANON
cannula
IMPLANON
4 cm
needle
How to Insert IMPLANON
• Insertion of IMPLANON should be performed under
aseptic conditions, and only by a health care provider
who is familiar with the procedure.
• Insertion of IMPLANON is performed with the specially
designed applicator. The use of this applicator differs
substantially from that of a classical syringe. A drawing
of a dismantled applicator and its individual components
(eg, cannula, obturator, and needle with double-angled
bevel) is shown in this leaflet to clarify their specific functions.
• The procedure used for insertion of IMPLANON
is opposite to giving an injection. When inserting
IMPLANON, the obturator must remain fixed while the
cannula (needle) is retracted from the arm.
• Allow the subject to lie on her back with her non-dominant
arm (the arm which the woman does not use for writing)
turned outward and bent at the elbow.
• To minimize the risk of neural or vascular damage,
IMPLANON should be inserted at the inner side of the
non-dominant upper arm about 8 to 10 cm above the
medial epicondyle of the humerus.
• IMPLANON should be inserted subdermally,
ie, just under the skin (subcutaneously).
• When IMPLANON is inserted too deeply
(intramuscularly or in the fascia), this may cause
neural or vascular damage. Too deep insertions
have been associated with paresthesia (due to
neural damage) and migration of the implant (due
to intramuscular or fascial insertion), and in rare
cases with intravascular insertion. Moreover, when
the implant is inserted too deeply, it may not be
palpable and localization and/or removal can be
difficult later.
• Mark the insertion site.
• Clean the insertion site with an antiseptic.
• Anesthetize with an anesthetic spray, or with 2 mL of lidocaine
(1%) applied just under the skin along the “insertion canal.”
• Remove the sterile disposable applicator carrying
IMPLANON from its blister.
• While keeping the shield on the needle, visually verify the
presence of the implant, seen as a white body inside the
needle tip. If the implant is not seen, tap the top of the
needle shield against a firm surface to bring the implant into
the needle tip. Following visual confirmation, the implant
should be lowered back into the needle by tapping it back
into the needle tip. The needle shield can now be removed.
• Please note that the implant can fall out of the needle prior
to insertion. Therefore, always hold the applicator in the
upward position (ie, with the needle pointed upward) until
the time of insertion. This is to prevent the implant from
dropping out. Keep the needle and the implant sterile.
If contamination occurs, a new package with a new sterile
applicator must be used.
Applicator for IMPLANON
IMPLANON ™ : Clinical Information
• IMPLANON is a subdermal, long-acting, progestagen-only
contraceptive effective for up to 3 years.
• The mechanisms of action of IMPLANON include inhibition
of ovulation and increases in the viscosity of cervical mucus.
• Efficacy does not depend on daily, weekly, or monthly
self-administration.
– IMPLANON is effective from day one, when inserted
according to instructions in the label.
• No method of contraception is 100% effective —
IMPLANON is over 99% effective when inserted
correctly. 1
– Studies show a continuation rate of 82% after 1 year of use.
2
– 11% of women studied discontinued IMPLANON due
to bleeding irregularities.
• Bleeding irregularities may include amenorrhea or infrequent,
frequent, and/or prolonged bleeding. Information, counseling,
and the use of a bleeding diary can improve the woman’s
acceptance of a bleeding pattern.
• Following removal of IMPLANON, the hormone is below
detectable levels within 7 days. 3
Bone Mineral Density
• A comparative study of IMPLANON and a non-hormonal
IUD showed that bone density remained unaltered over
2 years, with no detectable difference between users of
each contraceptive method.
Breast Milk
• Available data indicate that IMPLANON may be used during
lactation since it does not influence the production or
the quality of breast milk. However, it is important to be
aware that small amounts of etonogestrel are excreted in
breast milk.
• In clinical studies use of IMPLANON had no effect on the
production or quality of breast milk in nursing mothers.
Adverse Events
• Headache
• Weight increase
• Acne
• Breast pain
• Irregular menstruation
• Vaginal infections
Contraindications
• Use of IMPLANON is contraindicated in patients with:
– Known or suspected pregnancy
– Active venous thromboembolic disorder
– Presence of history of liver tumors
(benign or malignant)
– Presence or history of severe hepatic disease as long
as liver function values have not returned to normal
– Known or suspected sex-steroid sensitive malignancies
– Undiagnosed vaginal bleeding
– Hypersensitivity to the active substance or to any of
the excipients of IMPLANON
Drug Interactions
• Interactions can occur with medicinal products that
induce microsomal enzymes, specifically cytochrome
P450 enzymes, which can result in increased clearance
of sex hormones (eg, phenytoin, barbiturates, primidone,
bosentan, carbamazepine, rifampicin, and HIV medication
[eg, ritonavir, nelfinavir, nevirapine, efavirenz], and possibly
also oxcarbazepine, topiramate, felbamate, griseofulvin, and
the herbal remedy St. John’s wort).
Women on treatment with any of these drugs should
temporarily use a barrier method in addition to IMPLANON.
Please refer to the regulatory-approved full Prescribing
Information for additional interactions.
Pregnancy
• IMPLANON is not indicated during pregnancy. If pregnancy
occurs during use of IMPLANON, the implant should be
removed.
• Animal studies have shown that very high doses of
progestagenic substances may cause masculinization of
female fetuses. Extensive epidemiological studies have
revealed neither an increased risk of birth defects in
children born to women who used oral contraceptives
(OCs) prior to pregnancy, nor of a teratogenic effect when
OCs were inadvertently used during pregnancy. Although
this probably applies to all OCs, it is not clear whether this
is also the case for IMPLANON.
Key Points for Patient Counseling
• Women are likely to have changes in their menstrual
bleeding pattern with IMPLANON. These may include
changes in bleeding frequency, intensity, or duration;
however, the bleeding pattern experienced during the
first 3 months is broadly predictive of future bleeding
patterns for many women.
• Amenorrhea was reported in about 1 of 5 women
while another 1 of 5 women reported frequent and/or
prolonged bleeding.
• Dysmenorrhea tended to improve while using
IMPLANON.
• Appropriate counseling may make bleeding changes more
acceptable for women.
• Key counseling points include:
– Discussion of the likelihood of alterations in bleeding patterns
– Discussion of the risks, benefits, and possible side effects
• Explain the insertion and removal procedures; emphasize
that the implant should always be palpable and that scars
or complications may occur.
• If possible, provide patient education materials.
• Allow sufficient time for the patient to review the
educational materials, consider options, and ask questions.
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References:
1 – Graesslin 2008, 2 – Blumenthal 2008, 3 – Davies 1993
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